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	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with a ceramic electrode tip.According to the complaint description, the product fell apart in three (3) pieces.The surgeon was performing a laparoscopic myomectomy, bilateral salpingectomy, and removal of a permanent birth control device.The pieces fell apart outside the patient's body and not in the surgical field.The patient was not at any risk and a replacement device was opened to complete the procedure.(the tip is broken off as one piece.The second piece is the ceramic component, and the third piece is the metal cone.) additional information was not provided.The malfunction is filed under aag reference (b)(4).
Event or Problem Description
The malfunction is filed under aag reference (b)(4); cc (b)(4).
Additional Manufacturer Narrative
Investigation results: visual examination: the complaint device was returned to the manufacturer for evaluation.A visual examination was performed which revealed that the device returned in a used condition with visible loosened hooks.The hook (part # gk384202) was loosened from the main body (part # gk384200).Additionally, the device was sent to the production department for expert analysis.During production, the tensile strength of the hook is checked with a spring balance to confirm that the part can sustain a load of at least to 20 newtons (n).This device undergoes 100% testing in the semi-finished good stage as gk384800 to confirm a pull-off force of at least 20n to ensure that the connection will hold.No issue was noted with this part during this verification testing.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability 2(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: the hook may have loosened due to the application of an excess load from the outside.However, the root cause of the failure mode could not be detected.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.However, there is no indication of a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• 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 grun ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12275009
• Report Number: 9610612-2021-00533
• Device Sequence Number: 2754489
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 07/12/2021
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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
• Patient Sex: Female