MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP - SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	DBF-2.4SL-230SP-S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.An empty opened pouch from the product lot said to be involved was returned.Additionally, two sealed devices were returned from the product lot provided in the report.A review of the photos that the user provided was performed.Based on one of the four photos provided by the user, we can confirm that the cups are misaligned, however without the used device being returned a full evaluation cannot be completed.The two sealed devices were sent to the supplier for further evaluation.The supplier provided the following evaluation: two unused devices from the reported event were returned with proof of decontamination.The returned unused devices were tested for "teeth did not line up".During functional testing, with the device coiled in three (3), approximately eight (8) inch loops, it was confirmed that the device operated properly when the handle was manipulated.The devices open and close.Additional visual investigation under magnification of the closed jaws was performed.The teeth of the jaws were slightly misaligned with both devices, however both devices were within specification for alignment requirements.The reported defect of "teeth did not line up" could not be confirmed.The device history records for packaging work order were reviewed.The packaging work order consisted of one assembly order.This assembly order was manufactured in may 2017.All devices are inspected during final quality control (fqc) inspection for misaligned cups prior to release.There were relevant defects noted in the manufacturing and/or fqc 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: a review of the provided photos confirmed the report of misalignment, however a complete investigation could not be performed because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura serrated large forceps-spike are subjected to a visual inspection to ensure device integrity.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 an esophagogastroduodenoscopy (egd), the physician used a cook captura serrated large forcep - spike.On the third bite, the forceps cups looked crooked.The teeth did not line up.

• Brand Name: CAPTURA SERRATED LARGE FORCEP - 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: 6766588
• Report Number: 1037905-2017-00525
• Device Sequence Number: 1771284
• Product Code: FCL
• UDI-Device Identifier: 00827002536418
• UDI-Public: (01)00827002536418(17)200524(10)W3868956
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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-2.4SL-230SP-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2017
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1