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 Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

Product requested but not yet received.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The adverse event is filed under internal complaint id: (b)(4).

Event Description

Per the facility the cord started sparking during procedure and burnt hand of physician.No further information has been provided by the facility or status of user.

• 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, ; 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: 16028903
• MDR Text Key: 305943760
• Report Number: 9610617-2022-00334
• Device Sequence Number: 1
• Product Code: GEI
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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
• Device Lot Number: NO02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other