MAUDE Adverse Event Report: COOK MEDICAL COOK CUTTING LOOP

Catalog Number G46228

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2017

Event Type  No Answer Provided  

Event Description

While using the electrode cutting loop, during a turp procedure, the wire loop broke off.The wire loop was retrieved.All pieces were accounted for at the end of the case.No harm to the pt.

• Brand Name: COOK CUTTING LOOP
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47404
• MDR Report Key: 6971254
• MDR Text Key: 90307369
• Report Number: MW5072903
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: G46228
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 122