MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI KELLY FORCEPS INSERT

Model Number	38610MD
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Fire (1245)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the pneumoperitoneum was established with co2 at the beginning of the procedure, a malfunction occurred while using the forceps as it emitted a flame.The equipment was immediately removed from the patient and simultaneously disconnected." there is no information about patient harm.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the investigation on the returned products was completed on august 20,2024.The device history records (dhr) have been checked and found to be according to the specification, valid at the time of production.It is likely that the fault is caused by an overvoltage and the resulting high temperatures.The user manual refers to a possible overvoltage.Another possibility is a short circuit caused by liquid between the jaws.It is therefore important to check the products before use.The originator of this process is article 38610md, the remaining articles are therefore not considered further in the process.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ROBI KELLY FORCEPS INSERT
• Common Device Name: ROBI KELLY FORCEPS INSERT
• 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: 19711686
• Report Number: 9610617-2024-00192
• Device Sequence Number: 8608497
• Product Code: GEI
• UDI-Device Identifier: 04048551328682
• UDI-Public: 4048551328682
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K962030
• 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,Followup
• Report Date (Section B): 08/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 38610MD
• Device Catalogue Number: 38610MD
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 08/20/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/23/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 26176LE BIPOLAR HIGH FREQUENCY CORD, LOT: UNKNOWN.; 38151 ROBI PLASTIC HANDLE, LOT/SN: UNKNOWN.
• Patient Sex: Unknown