MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number G47692

Device Problems Difficult to Open or Close (2921); Component Misassembled (4004)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

The product was returned to the supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.

Event Description

Prior to a colonoscopy procedure, the physician prepared a cook captura pro¿ biopsy forceps with spike.When the customer opened the package and pre-tested the device, it had to be forced open and would not close after that.This occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the cups in the open position.The coating on the catheter was severely damaged during shipment to our facility.The packing is damaged and the material has worn away exposing the device.The covering on the catheter had fused together and when uncoiled from its looped position, the coating ripped off in multiple locations.From 11 cm to 14 cm the coating is damaged and coming off.From 75.5 cm to 78.5 cm the coating is peeling off and detached from the catheter.From 142.5 cm to 145 cm the coating is peeling off and has part of the pouch attached to the fused catheter material.From 297.5 cm to 210 cm the coating is completely missing from the catheter.During a function test the cups would not close when the handle was manipulated.There is no resistance felt in the handle when manipulating it to open or close the cups.The devices were returned to the supplier for further evaluation.The supplier provided the following evaluation: visual evaluation: device #1: a visual evaluation revealed several areas of gross damage to the hope sheath with some areas exposing the underlying coiled spring.Distal from the tip of the nose cap, damage was noted at 30.0-35.5 cm, 85.0-89.0 cm, 152-155.5 cm, and 216-220.5 cm.Device 2: no visual defects were detected.Functional evaluation: during testing, with the device held in straight, u-shaped, and three (3), 8 inch loop coiled positions, respectively, it was confirmed that the device did not operate properly when the handle was manipulated.The device did not open or close as designed.The reported event for "open/ close issue" was confirmed.Post initial functional testing, the handle spools were disassembled.It was noted that the pushrod clip was not properly seated in the housing.The pushrod clip was seated in the housing properly and the spools were reassembled.Then, the device opened and closed as designed.The device history records for the process traveler (pt) reviewed.The pt was manufactured june 2020.There were relevant defects noted in the manufacturing and/or final quality control checklist records.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 conclusion: the supplier provided the following: the damage to the sheath was incurred during return shipment of the device as was evident by the photos provided by the customer.The issue with open and close was due to the clip not being seated properly during assembly.Human error was the root cause.The customer complaint will be shared with the production manager to advise the operators involved in the assembly process of the process defect.Prior to distribution, all captura pro¿ biopsy forceps 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: a review of the complaint history was conducted.The likelihood of occurrence is considered remote.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: CAPTURA PRO BIOPSY FORCEPS WITH SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10541166
• MDR Text Key: 207180103
• Report Number: 1037905-2020-00385
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002476929
• UDI-Public: (01)00827002476929(17)230616(10)W4355347
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2023
• Device Model Number: G47692
• Device Catalogue Number: BF-2.2S-230SP-20
• Device Lot Number: W4355347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1