MAUDE Adverse Event Report: AESCULAP AG CERAMIC ELECTRODE TIP L-HK F/GK372R; REUSABLE INSTRUMENTS

Model Number	GK384R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap ag that a ceramic electrode tip l-hk f/gk372r (part # gk384r) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the device broke.Additional information was received on november 22, 2021 which revealed that a piece of the ceramic coating separated from the distal tip of the l-hook.The fragment was accounted for on the sterile back-table by the surgical tech and it was determined that it had separated prior to being used on the patient.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The surgery was prolonged approximately five (5) minutes as a result of this event.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information - b5, d9, h4.Corrected information - h6.Investigation: during a visual inspection of electrode "b" we noticed that a part of the ceramic insulation of the electrode is damaged/missing (chipped off).Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level ((4)5 severity x (2)5.Probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: the most probable root cause for ceramic-insulation defects on monopolar electrodes are dropping on hard surfaces, bending -stress of the metal within the electrode, and electrical overstress in conjunction with moisture.According to the case description, the electrode came defective from reprocessing.The instructions for use (ifu) points to checking the insulation of each electrode before use.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based on the investigation results a capa is not required.
Event or Problem Description
Update: the malfunction is filed under aag reference (b)(4).Associated medwatch report: 400533866 (9610612-2022-00265) gk384r - found broken prior to use.

• Brand Name: CERAMIC ELECTRODE TIP L-HK F/GK372R
• Common Device Name: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12854908
• Report Number: 9610612-2021-00731
• Device Sequence Number: 3840532
• Product Code: GEI
• UDI-Device Identifier: 04038653172504
• UDI-Public: 4038653172504
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K970541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: GK384R
• Device Catalogue Number: GK384R
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Sex: Unknown