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

Model Number	G56076
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 only fully close when the handle was held in the closed position.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.Due to the condition the device was returned in, the forceps were not function tested in the scope.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 device was returned to the supplier for an evaluation.The supplier provided the following: visual evaluation: the cups are misaligned, one cup is bent/twisted.Functional evaluation: a functional evaluation was not performed.One cup is bent causing the teeth to be misaligned.The device will not function properly with this condition.The device history records were reviewed.The manufacturing records and/or fqc checklist did include relevant defects.There were (b)(4) rejects for misaligned cups in the assembly order (ao).The condition of the bent cup is consistent with excessive force.The complaint was confirmed but the root cause was not determined.Therefore, a corrective action is not warranted.Investigation conclusion: the supplier provided the following: the condition of the device is consistent with excessive force.All devices receive a 100% inspection prior to shipment.This device would not have passed final inspection.Prior to distribution, all cook captura serrated large forcep-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.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
During a gastric biopsy procedure, the physician used cook captura serrated large forcep-spike.The product was "defective".Information was received on 03/09/2020, per the cc form, that the forceps would not open.Another set of forceps were used to complete the procedure.On 25-february-2020, the device was returned and determined to be misaligned.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.

• Brand Name: CAPTURA SERRATED LARGE FORCEP-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: 9856512
• Report Number: 1037905-2020-00152
• Device Sequence Number: 11415931
• Product Code: PTS
• UDI-Device Identifier: 00827002560765
• UDI-Public: (01)00827002560765(17)210709(10)W4090369
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 02/25/2020

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: 07/09/2021
• Device Model Number: G56076
• Device Catalogue Number: DBF-2.4SL-230SP-40-S
• Device Lot Number: W4090369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1