MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE

Model Number	26775UE
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	Gastroesophageal Burn (4475)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The event occurred in singapore: it has been reported that the overlap spade and the insulation of the coagulation and dissection electrode melted during activation and caused a burn in the patient.Internal reference number: (b)(4).
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.
Additional Manufacturer Narrative
According to the customer's statement and the damage pattern, it is likely that the item was used for too long or the hf switch was activated for too long.As a result, the thermal load at the distal end was too high, which led to a burn on the patient and to a melting of the insulation.In addition, the insulation in the second article was found to have a breakdown.This occurs when the peak voltage is above 3.0 kvp.The most probable root cause is a combination of two factors.The first factor is that the hf switch was used for too long, causing heat to build up at the distal end, leading to thermal damage.The second factor was most likely too high a peak voltage, which also contributed to heat generation and insulation breakdown.Therefore, it is concluded that the data/information specified by the ifu was not observed.
Event or Problem Description
Internal karl storz reference number: (b)(4).

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 15668000
• Report Number: 9610617-2022-00294
• Device Sequence Number: 7148983
• Product Code: GEI
• UDI-Device Identifier: 04048551072394
• UDI-Public: 4048551072394
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K944796
• 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): 11/15/2022

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: 26775UE
• Device Catalogue Number: 26775UE
• Device Lot Number: OQ03
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2019
• 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