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

Catalog Number	CL-2412-AC
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
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
The area representative reported, an (b)(6) year-old, male patient with a prostate tumor underwent a transurethral resection of the prostate (turp).During the procedure, while a cook cutting loop was being used, the middle of the cutting wire completely broke off inside the patient.The broken piece of wire was retrieved.This occurred twice during use of two (2) cook cutting loops.No unintended portion of the device was left in the patient¿s body.There was no need for any additional procedures due to this event.There was no adverse effect or consequence to the patient due to this occurrence.
Additional Manufacturer Narrative
A review of specifications 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.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.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering 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: 6947244
• Report Number: 1820334-2017-03575
• Device Sequence Number: 796142
• Product Code: GEI
• UDI-Device Identifier: 00827002462090
• UDI-Public: (01)00827002462090(17)200711(10)8055233
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CL-2412-AC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 03/02/2018
• 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: ACMI RESECTOSCOPE.
• Outcome Attributed to Adverse Event: Required Intervention