MAUDE Adverse Event Report: AESCULAP AG CERAMIC ELECTRODE TIP L-HK F/GK372R; HANDHELD PRODUCTS & LIGATION

Model Number	GK384R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a ceramic electrode tip l-hk f/gk372r (part # gk384r) was used during a laparoscopic procedure on (b)(6) 2024.According to the complainant the tip of device broke off into patient.Reportedly the surgeon was able to retrieve the broken part.A surgery delay of a few minutes was reported.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
The samples provided was returned to the manufacturing site for technical evaluation.Through visual examination, it was observed that the sample had a broken off hook and the broken off hook was not enclosed.Through microscopic evaluation, the ceramic insulation/body was in good condition, without cracks or chipped-off parts.The fracture surface on the body is typical for an overload fracture.No parts were missing.Based on the investigation, a definitive root cause could not be determined.The fracture surface shows no signs of a material failure or manufacturing error.Each electrode is 100% mechanically and electrically tested before delivery, so a production- related error can be ruled out.As a result, the reported failure could not be confirmed to be a manufacturing related issue.

• Brand Name: CERAMIC ELECTRODE TIP L-HK F/GK372R
• Common Device Name: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 19361372
• Report Number: 2916714-2024-00084
• Device Sequence Number: 14384531
• Product Code: GEI
• UDI-Device Identifier: 04038653172504
• UDI-Public: 4038653172504
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/03/2024
• Report Date (Section F): 05/21/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/03/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 10/03/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/21/2024