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

Model Number	GK384R
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
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 inner metal post detached.The device malfunctioned towards the end of the laparoscopic cholecystectomy procedure.The surgeon was removing the gallbladder from the liverbed, and the electrode tip was in two pieces.Each part of the tip which had fallen into the surgical field, was removed using a laparoscopic grasper.There was a less than five minutes delay due to the incident.The surgery was completed using another aesculap monopolar instrument.There was no described patient harm.Additional information was not provided.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results will be updated, once device is received by the manufacturer.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.Explanation and rationale unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Based upon the investigations results a capa is not necessary.
Event or Problem Description
An additional medical intervention was necessary.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital microscope and digital-camera.We made a visual inspection of the product.Here we found a loosened ceramic body.In addition, we carried out a visual inspection of the fracture surface.No abnormalities were detected, but we discovered unknown debris and black discoloration.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.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) probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: according to the quality standard a material defect and production error can be excluded.No abnormalities could be found on the point of rupture.Investigations lead to the assumption that the loosened ceramic body and hook were caused by a mechanical overload situation due to an improper handling.This leads to a breakage or loosening of the solder connection.Additionally there is the possibility for pre-damage or similar due to previous surgeries.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
• MDR Report Key: 11686225
• Report Number: 9610612-2021-00317
• Device Sequence Number: 16897813
• Product Code: GEI
• UDI-Device Identifier: 04038653172504
• UDI-Public: 4038653172504
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2021

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: GK384R
• Device Catalogue Number: GK384R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/23/2021; 06/18/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/19/2021; 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention