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 Problems Electrical /Electronic Property Problem (1198); Flare or Flash (2942)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Per the facility, during a bladder tumor procedure the uh801 bipolar hf cord sparked and burst inside the working element handle.The doctor's glove was burned but the doctor was not.There was no specific information provided regarding the harm if any to the patient.

• 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: 15258500
• MDR Text Key: 298226118
• Report Number: 9610617-2022-00246
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other