MAUDE Adverse Event Report: AESCULAP AG CERAMIC ELECTRODE TIP J-HK F/GK372R; LAPAROSCOPIC SURGERY

Model Number	GK383R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
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 to aesculap inc.That a ceramic electrode tip (part # gk383r) was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2020.According to the complainant, ceramic insulation was observed to be missing from the shaft, near the distal tip of the device.However, the damage was not identified by the surgical staff until the device was on the back table, so no determination could be made as to when the damage occurred.An x-ray was performed, but no fragments were identified.Additionally, the surgical staff checked the patient, and confirmed that no pieces were present.The surgery was delayed for an unspecified amount of time due to the x-rays that were performed.The device is available to be returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The adverse event / malfunction is filed under aag reference xc (b)(4).
Additional Manufacturer Narrative
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.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results there is capa is not necessary.
Event or Problem Description
No updates.

• Brand Name: CERAMIC ELECTRODE TIP J-HK F/GK372R
• Common Device Name: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10928799
• Report Number: 2916714-2020-00694
• Device Sequence Number: 2539125
• Product Code: GEI
• UDI-Device Identifier: 04038653172498
• UDI-Public: 4038653172498
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021
• Report Date (Section F): 12/01/2020

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: GK383R
• Device Catalogue Number: GK383R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 02/23/2021
• 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
• Date Report Sent to FDA: 12/01/2020