MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE

Model Number 26775UF

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

Reported device is not available for evaluation.Once the evaluation is complete, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the electrode was found to be damaged.Per report, the device was found to be damaged when it was sent to mdr for reprocessing after the surgery.The shaft and surrounding insulation were burned/melted and chipped away.The tip of the device was black and burned from use.According to the report, the reporter believed the issue happened during use because the mdr tested the device before use.It was unknown to the reporter if there was any injury.There was no report of intraoperative or post-operative complaints/issues at the time of the report.

Manufacturer Narrative

We were noified that the correct item number for the involved device was 26775uf (instead of 26870unl which was initially reported).Also, this item will later be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Type of Device: COAGULATING AND DISSECTING ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave.; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 18450981
• MDR Text Key: 332176103
• Report Number: 9610617-2023-00406
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 4048551072417
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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: 26775UF
• Device Catalogue Number: 26775UF
• Device Lot Number: ZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1