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

Model Number 26775UF

Device Problem Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 03/29/2024

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

The incident occurred during the procedure, causing the sheath to melt and resulting in burns to the patient.

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Type of Device: 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
• MDR Report Key: 19135504
• MDR Text Key: 340513710
• Report Number: 9610617-2024-00111
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 4048551072417
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K944796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26775UF
• Device Catalogue Number: 26775UF
• Device Lot Number: TN05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2022
• 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