MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO BIOPSY FORCEPS WITHOUT SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number	G47690
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.A follow-up emdr will be provided with the completed investigation.
Event or Problem Description
During a colonoscopy, the physician used three (3) cook captura pro¿ biopsy forceps without spike.The forceps did not close and the drive wire was exposed.The forceps were changed out to finish the 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.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed on the product said to be involved since it was not provided to cook for evaluation.The customer provided a picture of the device inside the patient.The picture shows the link wires for one of the cups sticking out the side from the forks.The cups are in the open position, but one of the cups appears stuck in the closed position.The open cup is the one with the link wire sticking out.The picture confirms the complaint, but from the angle the picture is taken, it can't be confirmed if the forks are narrow or not, and causing the malfunction of the device.The customer returned 50 sealed devices from the lot number in this report.The report was confirmed based on the returned sealed devices from lot #w4427777.The 50 sealed devices were evaluated functionally, by manipulating the handle to open and close the cups.A visual evaluation was done under magnification to check the forks for narrowness, which is caused by using the incorrect press at tip build.Of the 50 sealed devices, 27 devices were found to be non-conforming due to narrow forks.Device #34 was found to have functional issues, the cups were not opening and closing properly due to the link wires rubbing together inside the forks.The customer also returned an additional 56 sealed devices from lot w4443622.These sealed devices were evaluated functionally, by manipulating the handle to open and close the cups.A visual evaluation was done under magnification to check the forks for narrowness, which is caused by using the incorrect press at tip build.No non-conforming devices were identified.The device history records for the lot numbers said to be involved were reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the returned sealed devices from lot #w4427777 had 27 non-conforming devices, and device #34 had functional issues which affected opening/closing of the cups.The returned sealed devices from lot #w4443622 had no non-conforming devices identified.The report is confirmed and the supplier has been made aware of this issue.The supplier has implemented actions for short term and long term solutions.Prior to distribution, all captura pro¿ biopsy forceps without spike are subjected to a visual inspection and functional test to ensure proper workability.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 rare.The supplier has initiated actions to address the root cause.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 WITHOUT SPIKE
• Common Device Name: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11901121
• Report Number: 1037905-2021-00229
• Device Sequence Number: 1403245
• Product Code: PTS
• UDI-Device Identifier: 00827002476905
• UDI-Public: (01)00827002476905(17)240118(10)W4427777
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2024
• Device Model Number: G47690
• Device Catalogue Number: BF-2.2S-230-20
• Device Lot Number: W4427777
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE, PENTAX EC-349OLK; ENDOSCOPE, PENTAX EC-389OLK