MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA HOT BIOPSY FORCEPS; KGE, FORCEPS, BIOPSY, ELECTRIC

Catalog Number	HDBF-2.4-230-S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a visual inspection was performed on the device when it was received and the cups appear to be misaligned.From a visual inspection, we are able to see the inner portion of the bottom cup which suggests cup misalignment.The handle was manipulated and the cups opened and closed as intended.The device was sent back to the supplier for a full evaluation of the device.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 conclusions: we cannot adequately determine a root cause at this time because the investigation is still in process at our approved supplier.Prior to distribution, all captura hot biopsy forceps 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 hot biopsy forceps.After the facility inserted the forceps down the endoscope and cleared the endoscope they noticed a loose wire on the distal end.The complaint device was removed and a new g31583-hdbf-2.4-230-s [captura hot biopsy forceps] was opened and used to complete the procedure.The facility inspected their endoscope and there was no reported damage to it.After the device came back for investigation it was discovered on (b)(6) 2016 that the cups of the forceps were misaligned.
Additional Manufacturer Narrative
An emdr report was initially sent on 4/29/16, based on the observation that the forcep cups were potentially misaligned.The device was sent back to the supplier for further evaluation where it was determined that the cups were not misaligned.The supplier provided the following information: the visible cup wall thickness measured within specification.The device was opened and closed multiple times to confirm proper cup alignment.When put through the tortuous endoscope path, the cups remained aligned.The device link wires were properly positioned as determined under magnification.The distance between fork arm was less than the maximum allowed.The device does not have misaligned cups.The device history records for the packaging work order (pwo) were reviewed.Pwo consisted of one assembly order (ao).This ao was manufactured in december 2015.No relevant defects were noted in the 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.Based on the device evaluation, this incident no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This correction follow up report is being sent to cancel the initial report submitted relating to this event.

• Brand Name: CAPTURA HOT BIOPSY FORCEPS
• Common Device Name: KGE, FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5619404
• Report Number: 1037905-2016-00118
• Device Sequence Number: 13459438
• Product Code: KGE
• UDI-Device Identifier: 00827002315839
• UDI-Public: (01)00827002315839(17)190119(10)W3674455
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K923470
• 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,Followup
• Report Date (Section B): 12/16/2016

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-2.4-230-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1