MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. STORZ BIPOLAR CUTTING LOOP, DIAMETER 0.35MM; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES

Catalog Number REF: 27040GP-1

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

Patient was under anesthesia having a bipolar turp procedure.During the surgery, the bipolar cutting loop (looks like a long 7mm thin stick with a cutting wire) broke at the cutting wire.A piece of the cutting wire broke off in the patient.Another bipolar loop was reattached and again it broke but not by the wire.This time is broke on the side and was recovered.A third wire was attached with a different lot number and worked without fail.Fda safety report id# (b)(4).

• Brand Name: STORZ BIPOLAR CUTTING LOOP, DIAMETER 0.35MM
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; elsegundo CA 90245
• MDR Report Key: 10748512
• MDR Text Key: 213877545
• Report Number: MW5097507
• Device Sequence Number: 1
• Product Code: HIN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/26/2020

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 Expiration Date: 10/21/2020
• Device Catalogue Number: REF: 27040GP-1
• Device Lot Number: 37JII0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2020
• 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: 82 YR