MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR HIGH FREQUENCY CORD; BIPOLAR HIGH FREQUENCY CORD FOR KARL STORZ GENERATOR UH400U

Model Number UH801

Device Problem Arcing of Electrodes (2289)

Patient Problem Burn(s) (1757)

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned.Should the product be returned it will be evaluated and a supplemental report will be filed.

Event Description

Per received medwatch mw5111165, during a bipolar turp procedure a loud popping sound was heard with sparks of fire in surgeon's gloved hand.In addition, the screen temporary turned black.It was later reported the patient suffered a burn to the tip of his penis which was treated with antibiotic ointment.

• Brand Name: BIPOLAR HIGH FREQUENCY CORD
• Type of Device: BIPOLAR HIGH FREQUENCY CORD FOR KARL STORZ GENERATOR UH400U
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188100
• MDR Report Key: 15312238
• MDR Text Key: 302401687
• Report Number: 9610617-2022-00250
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551388778
• UDI-Public: 4048551388778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UH801
• Device Catalogue Number: UH801
• Device Lot Number: RO03-03907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other