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

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While the date aware was (b)(6) 2016, the manufacturer received new information on 30sept2016 which made this event reportable.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a patient underwent a transurethral resection of prostate (turp) procedure.During the procedure the cutting wire became detached.The urologist began working on resecting the prostate with the loop, at a setting of 120/80¿which is a common energy setting for this procedure, according to the tech.At some point a few minutes into the case, the physician removed the resectoscope to clear tissue from the loop, and saw that it was no longer there.The entire loop section of wire had burned up completely and disintegrated.He opened another loop, of the same lot, and it burned up as well.Both loops will be returned to investigations.The circulating nurse went to get another loop with a different lot number.Thus, allowing the surgeon to complete the case.Nothing was left inside the patient.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, complaint history, documentation, visual inspection and trends was conducted on the returned device during the investigation.The returned complaint devices were sent for failure evaluation.The visually inspected returned devices did not report any device failures.A review of the complaint history did not reveal any related production non-conformances or additional field failures associated with the suspect lot.Review of device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device utilizes an external power controller with specified settings for device application.It cannot be determined if the device, ancillary equipment or user technique contributed to the failure.Complete loss of the devices¿ active element along with evidence of charring on the electrodes indicates significant heat generation.This could be the result of incorrect settings, out of specification active elements, user technique, or an intermittent failure of the external power generating equipment.Based on the provided information and without additional evidences, a root cause cannot be identified.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: 6060166
• Report Number: 1820334-2016-01137
• Device Sequence Number: 18940853
• Product Code: GEI
• UDI-Device Identifier: 00827002462311
• UDI-Public: (01)00827002462311(17)190408(10)6877610
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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 Model Number: N/A
• Device Catalogue Number: CL-2612-30-OL
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1