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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event not provided by the reporter.(b)(4).Event is still under investigation at this time.
Event or Problem Description
During a transurethral resection of bladder tumor (turbt) on the patient, the loop broke during the procedure.The broken piece was removed from the bladder via graspers.Per information provided by the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record (dhr), documentation, instructions for use (ifu), manufacturing instructions, quality control and a visual inspection of the returned device was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: warnings and precautions do not bend or change the angle of the shape of the distal end.To do so may cause poor function, damage to the resectoscope and injury to the physician and / or patient; power settings vary greatly depending on the surgeon¿s preferences, technique, type of electrosurgical generator use and style tip.Maximum rated voltage for this device is 3000vp-p (ac).As a general guideline, the following power settings can be used.In the ¿cut ¿mode the power setting should be started low and increased gradually.Never exceed 200watts; in ¿coagulation¿ mode, the power setting should be started low and increased gradually.Never exceed 280watts.Caution must be taken to prevent arcing on high coagulation settings.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; do not use if there are breaks, scratches, and cracks in the insulation on the electrode.Use of the electrode with damaged insulation may cause unintended electrosurgical burns; care should be taken to avoid severe impacts, side stresses or bends at sharp angles.The visual inspection of the returned device reported: one single use electrode was returned with the cutting loop wire on the distal end of the device was not present; a small portion or fragment of the cutting loop wire was observed.The returned device was forwarded to the raw material vendor for further assessment.Visual inspection shows that loop is not present and tungsten loop does not appear to have been manipulated.The tungsten does have some charring which could have been a power setting issue.No other complaints have been received for this production lot.Without additional information regarding the procedure performed and settings of the generator an exact conclusion cannot be reached.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
During a transurethral resection of bladder tumor (turbt) on the patient, the loop broke during the procedure.The broken piece was removed from the bladder via graspers.Per information provided by the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5437976
• Report Number: 1820334-2016-00115
• Device Sequence Number: 588686
• Product Code: GEI
• UDI-Device Identifier: 00827002462281
• UDI-Public: (01)00827002462281(17)180827(10)6159716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/28/2016

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-2412-12-OL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2016
• Supplement Report FDA Received Date: 10/19/2016
• 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