MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA HOT SERRATED FORCEPS W/O SPIKE; KGE, FORCEPS, BIOPSY, ELECTRIC

Model Number	G56135
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
Initial reporter occupation: unknown.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The complaint was returned with a yellow liquid on the cups.The cups opened/closed when handle was manipulated.The device was advanced down the 2.8 olympus scope with little resistance and the cups opened/closed when the scope was placed in the retroflexed position.Upon further visual evaluation under magnification it was noted the cups were potentially misaligned and the cups would not close fully together.The supplier provided the following: visual evaluation of device: the device was visually evaluated.No defects to the handle were noted.The cups' assembly appeared misaligned and a kink was noted in the catheter approximately 66 cm distal from the handle.The device was evaluated for "cups potentially misaligned".Under magnification, the visible material thickness for the device was measured to be 0.011".The reported event for "cups potentially misaligned" was confirmed.Functional evaluation of device: the device was functionally evaluated.During testing, with the device held in straight, u-shaped, and three (3), 8 inch loop coiled positions, respectively, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as designed.Additionally, the device was advanced into the accessory channel of an olympus colonoscope (2.8 mm channel) which was placed in a simulated lower gi position.The distal end of the scope was retroflexed to simulate a worst case scenario.The device opened and closed as designed but was advanced and removed from the colonoscope without minimal resistance.The reported event for "difficult to advance/retract" was confirmed.The device history records manufactured august 2019 were reviewed and consisted of one assembly order(ao), manufactured september 2019.The manufacturing records and/or final quality control 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 complaint was confirmed but an assignable cause was not determined.Prior to distribution, all captura hot 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.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 colonoscopy, the physician used cook captura hot serrated forceps w/o spike.The physician had trouble getting the device down the endoscope.The physician used additional devices from the same gpn to complete the procedure.The complaint device was received on 04-feb-2020 and determined to be potentially 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 HOT SERRATED FORCEPS W/O SPIKE
• Common Device Name: KGE, FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9758281
• Report Number: 1037905-2020-00106
• Device Sequence Number: 16845787
• Product Code: KGE
• UDI-Device Identifier: 00827002561359
• UDI-Public: (01)00827002561359(17)221016(10)W4274388
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: 10/16/2022
• Device Model Number: G56135
• Device Catalogue Number: HDBF-2.4SN-230-S
• Device Lot Number: W4274388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1