MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED FORCEPS W/O SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number	G56125
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Align (2522)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: unknown.The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.
Event or Problem Description
In preparation for an endoscopic procedure, the physician selected cook captura serrated forceps w/o spike.The physician opened the package and detected the tip of the device bent and the cups were misplaced [misaligned].There was no use on the patient.The physician changed to another of the same device to complete the procedure.This occurred prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
Information regarding section e3 - initial reporter.Occupation: unknown.Investigation evaluation: our laboratory evaluation of the product confirmed the complaint as described by the user.The device was visually examined, and the cups appear to be potentially misaligned.During a functional test, the handle was manipulated, and the cups would open as intended but did not close as intended.There was no resistance felt in the handle when actuating the cups.However, there is a gap in between the cups and the teeth do not mesh correctly.No other anomalies were detected with the device.The device was sent back to the supplier for a full evaluation.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.The supplier provided the following: visual evaluation: the tip is bent.The length wires were not even during the solder process.The cups are misaligned.Functional evaluation: when the handle was actuated the tip did open and close.However, the tip is bent to one side causing the cups to be misaligned.Additional comments: the root cause of the bent tip is the uneven positioning of the link wires during the soldering process.A corrective action was issued to address this failure mode.A fixture was devised to reduce the movement of the wires during the soldering process.The corrective action was implemented in november of 2019.The date of manufacture for the supplier lot number involved was 02/2019.The device history records for packaging work order (pwo) were reviewed.The pwo consisted of one assembly order (ao).The manufacturing records and/or final quality control checklist did not include relevant defects.Investigation conclusion: the supplier provided the following: the corrective action was initiated november 2019.Specifically a fixture was fabricated to assist the operators with holding the device during soldering of the link wires.The date of manufacture for the supplier lot number involved was february 2019 which was prior to the implementation of the corrective action.Prior to distribution, all cook captura serrated forceps w/o 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.A corrective action has been initiated in an effort to reduce occurrences of this nature.This product was included in the scope of this corrective action and was manufactured prior to correction implementation.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
In preparation for an endoscopic procedure, the physician selected cook captura serrated forceps w/o spike.The physician opened the package and detected the tip of the device bent and the cups were misplaced [misaligned].There was no use on the patient.The physician changed to another of the same device to complete the procedure.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: CAPTURA SERRATED FORCEPS W/O 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: 9933057
• Report Number: 1037905-2020-00166
• Device Sequence Number: 3752699
• Product Code: PTS
• UDI-Device Identifier: 00827002561250
• UDI-Public: (01)00827002561250(17)220227(10)W4185429
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 02/27/2022
• Device Model Number: G56125
• Device Catalogue Number: DBF-2.4SN-230-S
• Device Lot Number: W4185429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1