MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STORZ BIPOLAR BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number UH801

Device Problems Fire (1245); Sparking (2595); Noise, Audible (3273)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/18/2022

Event Type  malfunction  

Event Description

During operating procedure for turp using storz bipolar a loud popping sound was heard.Reported by surgeon and cst of sparks of fire exploding in the surgeons hand, same was evidenced by burning smell, burnt glove.In addition anesthesia reported temporary screen black out.It was later learned that this pt suffered a burn to the tip of his penis which was treated with antibiotic ointment.Fda safety report id# (b)(4).

• Brand Name: STORZ BIPOLAR BOVIE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): KARL STORZ SE & CO. KG
• MDR Report Key: 15129682
• MDR Text Key: 296869809
• Report Number: MW5111165
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• 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: 07/27/2022

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 Model Number: UH801
• Device Lot Number: RO03-03907
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White