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

Catalog Number	BF-2.4SL-230SP-40
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During preparation for an unknown procedure, the physician chose a cook captura pro¿ biopsy forceps with spike.When the device was removed from the package, it was noted that the jaws were opened.It was then also noted that the handle was broken near the red neck area.This occurred prior to patient contact; there was no impact to the patient.
Event or Problem Description
During preparation for an unknown procedure, the physician chose a cook captura pro¿ biopsy forceps with spike.When the device was removed from the package, it was noted that the jaws were opened.It was then also noted that the handle was broken near the red neck area.This occurred prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the forceps cups in the closed position.When the handle of the device was manipulated the forceps cups would open, but would not close.During the functional test, the drive wire seems to be loose from the handle spool which could be causing the forceps cups to stay open when the handle spool is in the closed position.The device was sent back to the supplier for further evaluation.The supplier provided the following: one (1) device from the reported event was returned in a zip type bag with proof of decontamination.The device was evaluated.The spool travel is not restricted by the handle and the spool handle fully extended during the evaluation.The spool handle was fully compressed (pressed in) and the entire nose cap is visible.The device exhibited extensive spool travel.The spool is not restricted.When the device is actuated (move the handle) the cups of the forceps do not respond (open or close).The handle was then disassembled.The push rod clip of the device was not seated properly in the spool clip cavity.When the push rod clip is properly seated in the spool clip cavity the travel is restricted.The handle was then reassembled with the clip seated properly in the spool clip cavity.The device was then actuated and the forceps opened and closed.The complaint of "broke near the red neck area" was confirmed.No part of the device was broken, however it was not assembled properly and would not function.The device history records were reviewed.The assembly order was manufactured in november 2018.Relevant defects were 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 reported issue "forceps handle was broke" was determined to be a result of the push rod clip not being seated properly.The root cause was determined to be an assembly error and it was not caught at final inspection.The operators involved will be advised of the event.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 isolated 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.

• 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: 8305201
• Report Number: 1037905-2019-00041
• Device Sequence Number: 59539
• Product Code: PTS
• UDI-Device Identifier: 00827002506978
• UDI-Public: (01)00827002506978(17)211127(10)W4148419
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: 11/27/2021
• Device Catalogue Number: BF-2.4SL-230SP-40
• Device Lot Number: W4148419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1