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

Catalog Number DBF-2.4SN-230SP-40-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was not included in the return.However, 30 sealed devices were returned from the lot number provided in the report.The label matches the sealed devices returned.These 30 devices were sent to the supplier for further evaluation.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 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 an endoscopic procedure (either an esophagogastroduodenoscopy (egd) or colonoscopy), the physician used a cook captura serrated forceps with spike.The forceps would open but would not close.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was not included in the return.However, thirty (30) sealed devices were returned from the lot number provided in the report.The label matches the sealed devices returned.These thirty (30) devices were sent to the supplier for further evaluation.The supplier provided the following evaluation: thirty (30) devices from the manufacture lot number w3846751 were returned in their original pouches.The returned device was tested for "would not close" by coiling the devices in three (3) 8" loops.When the handle was manipulated, all devices opened and closed.Upon further investigation, the devices were inserted into a colonoscope in a torturous path configuration.The devices opened and closed as intended.The reported defect of "would not close" could not be confirmed.The device history records for the packaging work orders were reviewed.They were manufactured in february and march 2017.Relevant defects were noted during manufacturing and/or fqc (final quality inspection).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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The returned unused product functioned as intended.The customer experienced issue of "would not close" was not confirmed.No corrective action will be implemented at this time.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 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.

• Brand Name: CAPTURA SERRATED FORCEPS WITH 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: 6608544
• MDR Text Key: 76627931
• Report Number: 1037905-2017-00333
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002561335
• UDI-Public: (01)00827002561335(17)200330(10)W3846751
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4SN-230SP-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: 05/04/2017
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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