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

Catalog Number DBF-2.4-230SP-S

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined the cups do not line up properly when in the closed position.The returned device was visually inspected and there were no kinks or bends found throughout the coiled sheath.The handle of the device was manipulated and the forceps cups would open and close.Under magnification of the forceps cups from the side, one forcep cup was slightly protruding from the forceps cup housing.The cup was protruding from the forceps cup housing where the cup and one of the link wires are connected.A visual inspection from the top of the forceps cups was performed and the forceps cups appeared to be visually misaligned.The distal tip of the forceps device was visually examined and it was noted that one of the forceps cups appears to be tilted inward, which is possibly contributing to the misalignment.The device will be sent to the supplier for further evaluation.The supplier provided the following response letter: functional evaluation: the device was functionally evaluated.During testing, with the device coiled in three (3), 8" loops, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as intended.Misaligned cups evaluation: the device was evaluated for "misaligned cups." under magnification, the visible material thickness for the device was measured to be less than the thickness specification [within specification].The fork arms are relatively parallel.The reported event for "misaligned cups" was not confirmed.The device was also evaluated for "one forceps cup was slightly protruding from the forceps cup housing." no protrusions from the cup housing were detected and the cup tangs were also intact from a side view.In addition, the device was evaluated for "one of the forceps cup appears to be tilted inward." from a top view, one of the forceps cups does appear to be tilted.The device history records were reviewed.The assembly order for this lot was manufactured in april 2018.There were no relevant defects noted in the manufacturing and the final quality control checklist records.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.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 event from the end user, 'tip of cup not straight' was confirmed.The root cause was not determined but is believed to have occurred following release and shipment.The alignment of the cups meets specification.Therefore, the reported issue by the user for 'cups misaligned' was not confirmed.All devices receive a 100% inspection prior to release and shipment.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, fqc, 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 Description

In preparation for a biopsy procedure, the physician used a cook captura biopsy forceps with spike.They opened the package and checked the device and found the tip of the cup is not straight [forceps head bent], so they use another new device.There was no reportable information at this time.The device was evaluated on 26-july-2018 and it was determined that the cups do not line up properly when in the closed position.

• Brand Name: CAPTURA BIOPSY FORCEPS WITH SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7792665
• MDR Text Key: 117609994
• Report Number: 1037905-2018-00363
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002315853
• UDI-Public: (01)00827002315853(17)210423(10)W4059170
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2021
• Device Catalogue Number: DBF-2.4-230SP-S
• Device Lot Number: W4059170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1