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

Model Number	38610MD
Medical Device Problem Codes	Temperature Problem (3022); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, while coagulating, the forceps emitted a spark in the insert inside the patient (abdominal cavity).No negative impact in state of health reported.A report will be sent out as precautionary measure due to the spark inside the patient.
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).
Additional Manufacturer Narrative
Please see corrections in sections d1.D2, d4, g4, e1 and additional information provided in section d9 and d10.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: an user error is assumed to be the most probable root cause.The robi insert 38610md has burnt out/melted at the distal plastic insert.In addition, it can be seen that the contact wire has discolored on the inside at the weld (temper colors), the cause for both of these damages is an excessive temperature.(for example, incorrect settings, too long activation times of the hf current etc.).In addition, it was found that the plastic at the transition to the bayonet lock was probably damaged by mechanical force.On the shaft and on the handle, the age-appropriate signs of wear (dents, scratches,.) can be seen, but these did not lead to the failure of the forceps insert.In the corresponding ifu 97000117; version: 3.2 - 02/2020 the following is listed: warning: risk of injury: incorrectly assembled and damaged instruments can lead to injuries to the patient.Instruments and all of the accessories used in combination with them must be checked immediately before and after every use to ensure that they are complete, free from damage, and in full working order and have no unintentional rough surfaces, sharp corners, burred edges or projecting parts.Care must be taken not to leave missing or broken-off components inside the patient.Warning: risk of injury: overloading the instrument by exerting too much force may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original position.Caution: robi® instruments with hf connections are intended as endoscopic accessories to hf equipment for soft coagulation for a recurring peak voltage of max.150 vp and are only suitable for the shortterm coagulation of small hemorrhages.Usage with device settings of over 150 vp can lead to damage to the instrument (in accordance with iec 60601-2-2, 3rd edition).8.7 assembly, inspection and care the cleaned and disinfected medical device must be visually inspected for cleanliness, completeness, damage and dryness: if residues or contamination are still present, the medical device must be manually cleaned and subjected to a full cleaning and disinfection procedure once more.Damaged or corroded medical devices must be withdrawn from use.Joints, threads and glide surfaces must be lubricated locally with instrument oil (figs.7, 8).Dismantled medical devices must be assembled.· afterwards, a functional check must be carried out.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: 20412529
• Report Number: 9610617-2024-00369
• Device Sequence Number: 8445273
• Product Code: GEI
• UDI-Device Identifier: 04048551328682
• UDI-Public: 04048551328682
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2024

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
• Device Lot Number: WO16
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 12/12/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/02/2024; 12/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 38151 ROBI PLASTIC HANDLE; 38600 ROBI METAL OUTER SHEATH
• Patient Sex: Unknown