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

Model Number	G50697
Medical Device Problem Codes	Difficult to Open or Close (2921); Component Misassembled (4004)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
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.No kinks or damage were noted to the catheter, cups or handle.During a functional 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 device was sent back to the supplier for further evaluation.The supplier provided the following: visual evaluation of device: the visual evaluation detected that the spool housing was not located in the proper location.The spool housing was not restricted.There were no other visual defects detected.Functional evaluation of device: the device did not function.When the handle was actuated the forcep's jaws did not open and close.The device was disassembled and the pushrod clip was found to not be located in the clip cavity.The pushrod clip was put in the clip cavity.The device was reassembled.When the pushrod clip was put in the clip cavity the device function as intended.The device history records for process traveler (pt) w4327465 were reviewed.Pt w4327465 was manufactured march 2020.Relevant defects were not noted in the manufacturing and/or final quality control (fqc) 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 complaint was confirmed.Human error was identified as the root cause of the event.The operator did not place the push rod clip into the clip cavity.The production manager will be advised of the error and asked to communicate the findings to the operators involved.Prior to distribution, all captura pro biopsy forceps 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 and this represents an unusual occurrence.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.
Event or Problem Description
Prior to an endoscopic procedure, the physician selected a cook captura pro¿ biopsy forceps with spike.Preparing for the procedure, it was noted that the forceps would not open/close.It seemed like the drivewire was not connected in the handle.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: CAPTURA PRO BIOPSY FORCEPS WITH 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: 10476796
• Report Number: 1037905-2020-00345
• Device Sequence Number: 2757506
• Product Code: PTS
• UDI-Device Identifier: 00827002506978
• UDI-Public: (01)00827002506978(17)230305(10)W4327465
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: 03/05/2023
• Device Model Number: G50697
• Device Catalogue Number: BF-2.4SL-230SP-40
• Device Lot Number: W4327465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1