MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC INSTINCT ENDOSCOPIC HEMOCLIP; MND, LIGATOR, ESOPHAGEAL

Catalog Number INSC-7-230-S

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

During the colonoscopy procedure, a cook instinct endoscopic hemoclip was used to treat a post polypectomy defect.The clip was advanced through the endoscope to the clipping site.The clip closed onto the tissue but would not release from the deployment device.The clip was removed in a closed position and another clipping device made by another manufacturer was used to finish the originally intended procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

A product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.However, an unused device from the lot number said to be involved was returned for evaluation.Regarding the unused device: the foam tip protector was correctly in place.An increase in resistance was observed in the movement of the drive wire once the clip was pulled halfway into the housing prior to deployment.The device was advanced into a pentax ex3830-tl colonoscope in a simulated lower gi position with the tip in the maximum retroflexed position to simulate a worst case position.The clip was successfully deployed on simulated tissue by applying an expected amount of force to the handle spool.Therefore this device functioned as intended.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Resistance encountered while attempting to deploy the clip after the clip is closed on the tissue (i.E.Difficult with clip release) can lead to damage of device components such as the hook at the distal end of the drive wire of the security of the drive wire to the handle.The instructions for use instruct the user to verify smooth handle operation and clip operation prior to use.Instructions for use state to permanently deploy clip, pull handle spool toward handle thumb ring until clip detaches.Note: if separation of clip is not immediate, gently move catheter back and forth or use other endoscopic maneuvers to separate catheter from clip.Instruction for use state if clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur.Prior to distribution, all instinct endoscopic hemoclips are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that he lot said to be involved met all manufacturing requirement prior to shipment.Corrective action: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.Quality assurance will continue to monitor for complaint trends.

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Type of Device: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manager ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3697939
• MDR Text Key: 4227803
• Report Number: 1037905-2014-00008
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2016
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W3264079
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)