MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA, INC. UNIPOLAR/BIPOLAR COAGULATION; COAGULATION - CUTTER, ENDOSCOPIC UNIPOLAR (AND ACCESSORIES)

Model Number 30675 ND

Device Problems Break (1069); Material Fragmentation (1261); Smoking (1585)

Patient Problem Burn, Thermal (2530)

Event Date 10/02/2018

Event Type  Injury  

Event Description

Patient procedure began and surgeon requested the storz bipolar coagulation/ dissection device.The surgeon nor the operating room tech noted anything wrong with the device.When the cautery used, the surgeon and tech noted a small amount of smoke and a few small black fragments.The surgeon removed the device, he and the operating room tech noted a small area on the instrument where the device had a break in the insulation approximately 1 cm from the tip.The surgeon then examined the patient laparoscopically again and noted a through and through burn to the patients left fallopian tube.The instrument had been cleaned and sterilized appropriately according to manufactures instructions for use.The storz instrument had been inspected prior to sterilization using the insuscan and no defects were found.

• Brand Name: UNIPOLAR/BIPOLAR COAGULATION
• Type of Device: COAGULATION - CUTTER, ENDOSCOPIC UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA, INC.
• MDR Report Key: 7946733
• MDR Text Key: 123265417
• Report Number: MW5080396
• Device Sequence Number: 1
• Product Code: KNF
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30675 ND
• Device Catalogue Number: 30675 ND
• Device Lot Number: XV05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 31 YR
• Patient Weight: 55