| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-01006-1 |
| Product Name/Description |
Instinct Plus Endoscopic Clipping Device
Reference part Number: INSC-P-7-230-S
GPN: G58010
Lot Numbers: All
UDI: 00827002580107
ARTG 96698
(William A Cook Australia Pty Ltd - Gastrointestinal endoscopic clip, long-term) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2024 |
| Responsible Entity |
|
| Reason/Issue |
Cook Medical has received reports of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle. The malfunction that may occur is the clip housing detaching from the catheter attachment and the clip remaining attached to the drive wire. The clip will extend from the catheter, but it will remain attached to the internal drive wire instead of opening the clip jaws. The clip cannot be opened if this occurs.
Potential adverse effects to the patient that may occur if the clip does not deploy as intended are injury (bleeding, laceration, perforation, etc.) requiring additional interventions. Potential adverse effects to the patient that may occur if there is a significant delay in the haemostasis procedure are additional interventions or medications needed to stabilise the patient, bleeding requiring additional haemostasis, surgical intervention, hospitalisation, or death. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Cook Medical is investigating this problem to determine appropriate actions to address this problem. Customers will be notified when more information is available.
In the interim customers may continue to use these devices following the IFU, specifically:
1.“Precaution – Do not continue to pull handle spool beyond tactile resistance as this may prematurely deploy clip” and “With clip closed and without holding handle spool advance device in small increments into accessory channel of gastroscope, duodenoscope, or colonoscope.” “Holding handle spool during clip advancement may prematurely deploy clip.”
2.Confirm the device opens and closes appropriately prior to advancing through the endoscope. When advancing through the endoscope the user should not hold the handle spool (white portion of handle). Although designed to reopen after closure on tissue, reopening may cause this malfunction to occur if the clip is partially deployed during the process of closing onto the tissue. |
| Contact Information |
1800 777 222 - Cook Medical |