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

Catalog Number	DBF-2.4SN-230SP-40-S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report.However we can confirm that during a visual inspection of the returned device, the device was returned in two (2) different pieces.The device was cut near the distal end.The device was cut at 227.8 cm from the distal end of the handle.When the handle is manipulated the drive wire will advance and retract from the coiled sheath.On the distal end piece that was returned, the drive wire was partially sticking out that leads down to the solder joint.The distal end of the drive wire was tugged on and it would not come free from the end of the device.The device was sent back to the supplier for further evaluation.The supplier provided the following evaluation: one device was returned in a zip type bag with proof of decontamination.The returned device could not be completely functionally tested due to device damage.The device was returned with cups intact, but was damaged and cut approximately 228 cm from the distal end of the handle.However, when the handle was manipulated, the drive wire moved back and forth accordingly, indicating the device functioned appropriately.Lastly, the distal tip was disassembled to investigate the solder joint.The solder joint was found to be intact.The reported defect of "unable to remove from endoscope" could not be confirmed.Unable to determine the cause due to device damage.The device history records were reviewed.The assembly orders for this lot were manufactured in may 2017.No relevant defects were noted in the manufacturing and/or 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 reported issue "not able to pull forceps out of the endoscope" was not confirmed.A definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use states 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." the instructions for use states: "using slight pressure on handle, close forceps around tissue or object.Note: it is not necessary to apply excessive pressure to cleanly excise tissue.Caution: if forceps fail to close, slowly pull cups against channel opening.Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope." prior to distribution, all captura biopsy forceps 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 biopsy procedure, the physician used a captura serrated forceps with spike.After taking a piece of tissue, they were not able to pull forceps out of the endoscope.They had to remove the entire endoscope with the forceps and cut off the tip of the forceps and then removed the rest of the device from the endoscope.The following was confirmed by the sales representative on 10/26/2017: the user felt as if they could not remove the forceps from the endoscope because they would not close, therefore they removed the entire endoscope from the patient and cut the forceps to remove them from the endoscope channel.

• Brand Name: CAPTURA SERRATED FORCEPS WITH 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: 6983246
• Report Number: 1037905-2017-00660
• Device Sequence Number: 518540
• Product Code: FCL
• UDI-Device Identifier: 00827002561335
• UDI-Public: (01)00827002561335(17)200601(10)W3872726
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/27/2017

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-2.4SN-230SP-40-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/27/2017
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1