MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATION SUCTION TUBE, 3 MM

Model Number	839310N
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that an alleged case of a diathermy burn sustained by a patient during surgery on (b)(6) 2024.
Additional Manufacturer Narrative
Result of investigation: damage can be seen on the insulation of the suction tube and the material is beginning to corrode in the bare areas - corrosion at the distal end of the suction tube.Based on the damage to the insulation of the product, it can be assumed that the insulation was already damaged before use (due to wear, during reprocessing, etc.) during use, the hf current could then spread to the body through the weakened/damaged insulation and thus lead to burns at the contact points.The corresponding ifu (97000060; version: 4.3 - 06/2024) warns against the use of hf current: "risk of injury: there is a risk of injury if the insulation on hf instruments is damaged do not use hf instruments with damaged or missing insulation." the device history records have been checked and found to be according to the specification, valid at the time of production.No further complaints against the same lot number.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATION SUCTION TUBE, 3 MM
• Common Device Name: COAGULATION SUCTION TUBE, 3 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20258435
• Report Number: 9610617-2024-00321
• Device Sequence Number: 7564153
• Product Code: EOB
• UDI-Device Identifier: 04048551207727
• UDI-Public: 04048551207727
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 839310N
• Device Catalogue Number: 839310N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown