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 Codes	Break (1069); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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used a cook captura pro¿ biopsy forceps without spike.The whole tip of the biopsy forceps came apart.The scope was withdrawn from the patient and the forceps were carefully removed and examined to make sure all parts were accounted for.The scope was then re-advanced and new forceps were used to take biopsies.There was no reportable information at this time.The device was evaluation on 15 april 2021 and it was determined the forceps cups would not close [subject of the report].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: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the cups in the open position and the cup housing tromboning from the sheath.The cups would not close using the handle due to the housing coming apart and detaching from the sheath.The device would trombone when handle was manipulated.The weld marks were visible on the housing of the cups and on the metal portion of the sheath.Under magnification the housing appeared to have sufficient welds and are within the weld zone.The device was sent back to the supplier.The supplier provided the following: visual evaluation: the device was visually evaluated.No defects to the handle or catheter were noted.The cups' assembly, specifically the forks, were visually detached from the coiled cable.The detached forks resulted in exposed coiled cable and the cups were in the open position.Weld marks were detected both internally and externally on the forks as well as on both sides of the exposed coiled cable.Weld marks appeared to be sufficient on the forks and were within the weld zone.The reported event for "detached tip" was confirmed.Functional evaluation: the device was functionally evaluated.During testing, with the device held in straight, u-shaped, and three (3) 8" loop coiled positions, respectively, it was confirmed that the device did not operate properly when the handle was manipulated.The device cups did not open or close due to the detached forks from the coiled cable.Additionally, when the handle was manipulated to simulate the opening and closing of the device, the link wires would extend and retract.The reported event for "detached tip" was confirmed.The device history records for process traveler (pt) w4394618 (800) manufactured october 2020 were reviewed.The manufacturing records and/or fqc checklist did not indicate relevant defects.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 root cause was not determined.No corrective action has been assigned.All devices receive a 100% inspection prior to release and shipment.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 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 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: 11813082
• Report Number: 1037905-2021-00193
• Device Sequence Number: 17085478
• Product Code: PTS
• UDI-Device Identifier: 00827002476905
• UDI-Public: (01)00827002476905(17)231013(10)W4394618
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/06/2021

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: 10/13/2023
• Device Model Number: G47690
• Device Catalogue Number: BF-2.2S-230-20
• Device Lot Number: W4394618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/06/2021
• 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, UNKNOWN MAKE OR MODEL.; ENDOSCOPE, UNKNOWN MAKE OR MODEL.