MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-NO SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number DBF-2.4SL-230-40-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Only one device was returned.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was advanced down an olympus 2.8 mm channel endoscope.The endoscope was then placed in a curved position.When the handle of the device was manipulated the forceps cups will open and close as intended.A visual inspection of the handle was performed and no issues were identified.The device will be sent back to the supplier for further evaluation.Investigation conclusion: the product was returned to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.

Event Description

During a colonoscopy, the physician used two (2) captura serrated large forcep-no spike.The forceps were broken at the handle.The following was received on 10/09/2017 per the sales representative: "each of the forceps that the customer reported had broken at the handle were tested (outside the endoscope) once given to me.They did not feel as if they were functioning correctly, meaning that they felt as if the drive wire or a set screw was loose or broken.This affected the opening and closing of the cups.".

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was advanced down an olympus 2.8 mm channel endoscope.The endoscope was then placed in a curved position.When the handle of the device was manipulated the forceps cups will open and close as intended.A visual inspection of the handle was performed and no issues were identified.The device will be sent back to the supplier for further evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.Evaluation of the device determined that the returned device was tested for "broken at handle." the device was examined for damage to the handle and no damage was detected.During functional testing, with the device coiled in three (3), 8 inch loops, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as intended.The reported defect of "broken at handle" was not confirmed.The device history records were reviewed.The assembly order for this lot was manufactured in june 2017.No relevant defects were noted in the records.A request made to the supplier to check the measurement of the set screw that is in the handle spool.The length of the set screw was within the specification.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 "broken handle" issue experienced by the customer was not confirmed.During functional testing, the device operated properly.The instructions for use regarding product inspection states: "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 forcep-no 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.

• Brand Name: CAPTURA SERRATED LARGE FORCEP-NO SPIKE
• Type of Device: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): 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: 6931194
• MDR Text Key: 90039451
• Report Number: 1037905-2017-00632
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002560598
• UDI-Public: (01)00827002560598(17)200621(10)W3880228
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4SL-230-40-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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