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

Model Number	N/A
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that the physician was performing a transurethral resection of bladder tumor (turbt) procedure by using a cook cutting loop.The physician noticed that the cook cutting loop disengaged from the resectoscope, which caused loss of electric current.The physician used a different manufacturer¿s cutting loop to complete the procedure.No unintended section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation summary: a review of complaint history, device history record, documentation, instructions for use, specification and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.The device history record was reviewed and no non-conformances were identified.A thorough review of complaint history search revealed that this is the only recorded complaint associated with this lot number.A 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.Based on the provided information, no product returned and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 6727839
• Report Number: 1820334-2017-01715
• Device Sequence Number: 855949
• Product Code: GEI
• UDI-Device Identifier: 00827002462038
• UDI-Public: (01)00827002462038(17)200302(10)7720072
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/15/2017

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-2414-KS2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1