MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATION SUCTION TUBE, 3.5 MM

Model Number	8606F
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer will not return the device for evaluation, thus we are unable to forward it to the manufacturing site.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).
Event or Problem Description
It was reported that during a procedure on (b)(6) 2024, the insulation on the instrument was damaged and caused a burn on a patient.No further information was provided.

• Brand Name: COAGULATION SUCTION TUBE, 3.5 MM
• Common Device Name: COAGULATION SUCTION TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 19801271
• Report Number: 2020550-2024-00220
• Device Sequence Number: 12859210
• Product Code: EOB
• UDI-Device Identifier: 04048551213698
• UDI-Public: 4048551213698
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2024
• Report Date (Section F): 07/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8606F
• Device Catalogue Number: 8606F
• Device Lot Number: SQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/27/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown