MAUDE Adverse Event Report: KARL STORZ STORZ; BIPOLAR CUTTING LOOP

Catalog Number 27040GP1

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

The loop on the bipolar cutting loop broke.

• Brand Name: STORZ
• Type of Device: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ
• MDR Report Key: 4331450
• MDR Text Key: 5137958
• Report Number: MW5039604
• Device Sequence Number: 1
• Product Code: FAS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 27040GP1
• Device Lot Number: 48778
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2014
• Patient Sequence Number: 1