MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA BIOPSY FORCEPS WITHOUT SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	DBF-2.4-230-S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the cups were potentially misaligned.The device was returned with no sign of damage to the sheath.During a functional test, the cups will open and close when the handle is manipulated.When the cups were in the closed position, a visual inspection was performed under magnification to inspect the forceps cups.During the visual inspection, the forceps cups appear to be misaligned.Further, during the visual inspection, it was also observed that one of the forceps cups appears to be twisted and pointing inwards.Due to the forceps cups being misaligned, the device was not advanced through an endoscope.The device was sent to the supplier for further evaluation.The supplier provided the following response: one (1) device from the reported event was returned in a zip type bag with proof of decontamination.The returned device was functionally evaluated.During testing, with the device coiled in three (3), eight (8) inch loops, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as intended.The device was also evaluated for "forceps cups appear to be misaligned".Under magnification, the visible material thickness for the device was measured to be less than the thickness specification.Measured in two places under magnification, the distance between fork arms for the device are relatively parallel.The evaluation of the device did not reveal any device defects.The device history records were reviewed.The assembly order for this lot was manufactured in january 2018.There were no relevant defects noted in the manufacturing and the 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 cups cannot be misaligned more than the material thickness and the cups were within specification.The reported issue for "misaligned cups" was not confirmed.Although the supplier evaluation was unable to confirm the report, the internal evaluation confirmed the report based on the visual inspection that the forceps cups were misaligned.Prior to distribution, all captura biopsy forceps without spike are subjected to a visual inspection to ensure device integrity.The device goes through several different inspections in manufacturing, final quality control, and packaging departments prior to leaving the facility in an effort to ensure cup alignment.Therefore, it is unknown how or at what point the cups became misaligned at the distal end.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 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
During a biopsy procedure, the physician used a cook captura biopsy forceps without spike.Per the user, it was impossible to take a sample for biopsy.The forceps did not cut the mucosa when the spoon [cups] closed.There was no sharp edge on the spoon cut [forceps cups].They changed the forceps [to complete the biopsy].There was no reportable information at this time.The device was evaluated on 05/22/2018 and the forceps cups were found to be potentially misaligned.The supplier evaluation was received on 06/13/2018.The forceps cups were found to be aligned.However, there was a gap between the edges of the cups.

• Brand Name: CAPTURA BIOPSY FORCEPS WITHOUT SPIKE
• Common Device Name: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7607546
• Report Number: 1037905-2018-00255
• Device Sequence Number: 19365407
• Product Code: FCL
• UDI-Device Identifier: 00827002315761
• UDI-Public: (01)00827002315761(17)210125(10)W4024447
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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 Catalogue Number: DBF-2.4-230-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2018
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1