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

Model Number	G46218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: nurse manager.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, documentation, and specifications.The complainant returned one used product inside a clear protective tube for investigation.Physical examination confirmed the loop at the top of the device is broken.A review of the device history record revealed there are no related non-conformances associated with the complaint device lot.No other lot related complaints have been received.The device was sent to the supplier for further investigation.Visual inspection of returned sample was done.Loop was detached from the electrode.Under magnification there is evidence of the loop being manipulated post-manufacturing (loop angle has been altered).No corrective action was needed because there were no manufacturing defects.The supplier provided additional information to clarify their investigation.The loop portion of the electrode is tungsten.The devices 100% inspected in process for loop angles and again by sample at the qc inspection.The tungsten loops are also 100% inspected under magnification for any cracks/ breaks at final inspection.Any alteration of the loop angle post-manufacturing can cause it to crack/ break.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Based on the returned device analysis by the supplier it appears the cutting loop has been manipulated post manufacturing and this could have contributed to the complaint.The cause of the complaint cannot be established.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
It was initially reported, during a transurethral resection of bladder tumor (turbt) using storz resectoscope, the cook cutting loop became loose but not detached during the procedure.No harm to patient.Opened another cutting loop and finished procedure.The device failure analysis performed by the manufacturer on 01apr2019, found the returned cutting loop was broken, not loose as was initially reported.As reported, no unintended section of the device remained inside the patient's body.No additional procedures were required and there were no adverse effects on the patient as a result of 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: 8520936
• Report Number: 1820334-2019-00812
• Device Sequence Number: 19294320
• Product Code: GEI
• UDI-Device Identifier: 00827002462182
• UDI-Public: (01)00827002462182(17)211009(10)9220907
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 10/09/2021
• Device Model Number: G46218
• Device Catalogue Number: CL-2412-KS1
• Device Lot Number: 9220907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1