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

Catalog Number	CL-2612-AC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during a trans urethral resection of prostate (turp) procedure, the loop of the cook cutting loop broke off in the patient's bladder.As reported, the portion of the broken device was retrieved from the patient.A second cook cutting loop was used to complete the procedure without difficulty.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
A visual inspection of the returned devices was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, and manufacturing instructions.The complaint device was not returned.Five unopened packages with part number cl-2612-ac and label lot number 8458407 were received.The packages were not opened.All five devices were returned to the supplier for investigation.The supplier investigation reported the samples that were returned were visually inspected through the packaging and all loops were intact.Supplier also reported there were no manufacturing defects.Supplier advised the photo provided showed the piece retrieved is the whole loop.It appears the loop did break off the legs of the electrode.The loop in the photo cannot be verified to be part of this lot.A review of the device history record found there were no non-conformances associated with the complaint device lot number.A search of complaint records revealed this is the only complaint for complaint device lot number 8458407.The following information can be found in the instructions for use (ifu) that accompanies this device.Warnings and precautions 4.Do not bend or change the angle or shape of the distal end.To do so may cause poor function, damage to the resectoscope and injury to the physician and/or the patient.8.Immediately discontinue use if breaks or fractures appear in the device.These conditions may allow undirected emission of electrical energy, rendering the device useless and potentially causing harm to surrounding tissues.10.Care should be taken to avoid severe impacts, side stresses or bends at sharp angles.Directions for use 1.Remove the device from the package and examine it for damage.Do not use if there are visible signs of damage, or if the insulation is not intact.Although unused devices from the same lot were returned they did not provide evidence to help determine the root cause of the complaint.The actual complaint device was not returned.An image was provided that showed the cutting loop had broken off the legs of the electrode.The cause of this complaint could not be established.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There has been no new information received since the last report was submitted.

• 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: 7714374
• Report Number: 1820334-2018-02057
• Device Sequence Number: 19109409
• Product Code: GEI
• UDI-Device Identifier: 00827002462113
• UDI-Public: (01)00827002462113(17)201219(10)8458407
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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 Expiration Date: 12/19/2020
• Device Catalogue Number: CL-2612-AC
• Device Lot Number: 8458407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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: ASKU