MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. INSTINCT ENDOSCOPIC HEMOCLIP; MND, CLIP, HEMOSTATIC

Catalog Number INSC-7-230-S

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

During an endoscopy procedure, a cook instinct endoscopic hemoclip was used.The clip was opened and closed onto the tissue successfully, but would not release from the catheter.The clip was gently pulled off the site without incident, and a clip from another manufacturer was used to complete the procedure.A section of the device did not remain inside the pt's body.The pt did not require any add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation eval: a product eval was not performed in response to this report because the product said to be involved was not provided to cook for eval.The report could not be confirmed.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.Investigation conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for eval.A definitive cause for the reported observation could not be determined.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.Instructions 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 the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Type of Device: MND, CLIP, HEMOSTATIC
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4751423
• MDR Text Key: 5826545
• Report Number: 1037905-2015-00171
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132809
• 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: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2018
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W3531068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2015
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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 COLONOSCOPE, MODEL #: UNK