MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA HOT SERRATED FORCEPS W/O SPIKE; KGE, FORCEPS, BIOPSY, ELECTRIC

Catalog Number	HDBF-2.4SN-230-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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 instructions for use states: "if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." prior to distribution, all captura hot serrated forceps w/o spike are subjected to a visual inspection and functional testing 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 actions: 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 colonoscopy procedure, the physician used a cook captura hot serrated forceps w/o spike.As reported to customer relations: "during a colonoscopy procedure the device was placed down the endoscope and while under magnification the physician noted frayed sheathing and metal.[forceps outer sheath is damaged].Removed the device and used another of the same product to complete the procedure.".

• Brand Name: CAPTURA HOT SERRATED FORCEPS W/O SPIKE
• Common Device Name: KGE, FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6285715
• Report Number: 1037905-2017-00036
• Device Sequence Number: 1001645
• Product Code: KGE
• UDI-Device Identifier: 00827002561359
• UDI-Public: (01)00827002561359(17)190913(10)W3768983
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/31/2017

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: HDBF-2.4SN-230-S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS CF 180 ENDOSCOPE