MAUDE Adverse Event Report: COOK INC COOK CUTTING LOOP; GEI UNIT, ELECTROSURGICAL AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
It was reported by the user facility that a patient underwent a prostate procedure.The cook cutting loop was the device in use.The attending physician was attempting to remove the scope from the patient when he realized the loop was broken.The physician was able to retrieve the broken pieces of the loop by hand from the patient and proceeded to complete the surgery successfully.As a result of this event, no unintended sections of the device remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, complaint history, visual inspection and specifications was conducted on the returned device during the investigation.The device was returned for evaluation.Physical examination of the returned device was performed.Visual inspection of the returned unit shows that the loop has broken off of the electrode.The loop was detached but intact.The proximal contact wire was bent.Other than the loop being detached, all components were present but dimensional analysis and could not be done.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The cutting loop on the distal end was separated from the prongs; loop broke off even with the prongs.Point of loop separation on loop had a discolored appearance.Conclusion: the loop breaking off the electrode was post-manufacturing and cannot be confirmed as a manufacturing defect.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• Brand Name: COOK CUTTING LOOP
• Common Device Name: GEI UNIT, ELECTROSURGICAL AND ACCESSORIES
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6420281
• Report Number: 1820334-2017-00492
• Device Sequence Number: 13688732
• Product Code: GEI
• UDI-Device Identifier: 00827002462199
• UDI-Public: (01)00827002462199(17)191021(10)7377107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K935874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CL-2414-KS1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR