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
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.
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).
Additional Manufacturer Narrative
Per investigation conducted by the manufacturing site: as the product has not been returned, a final determination of the root cause is not possible.It was reported that the insulation on instrument was damaged and caused a burn on a patient.By reviewing the failure description, it is most likely that the insulation may have been damaged during reprocessing or during use in contact with other sharp instruments, for example.Due to the defective insulation, the current could jump into the patient, resulting in burns.The ifu advises you to check the item for damage.It is most likely that this was not done properly and therefore the incident can be assumed as user fault.This event is filed under internal complaint id (b)(4).

• 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
• 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: 19798072
• Report Number: 9610617-2024-00220
• Device Sequence Number: 19870769
• Product Code: EOB
• UDI-Device Identifier: 04048551213698
• UDI-Public: 04048551213698
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown