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

Model Number	GK384R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
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) 2023.According to the complainant as the device was coming out of the patient the tip of the l hook was seen laying inside the patient.During extraction of the tip the device broke into two separate pieces.Both fragments were successfully retrieved from the patient.Per the complainant the procedure was delayed by an unspecified amount of time.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Additional information/correction: d9 - product return date.Investigation results: investigator carried out the pictorial documentation visually and microscopically.The hook is broken off of the product.Device 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.Investigation results were based on examination of the same material from another complaint.The assessment for reportability for this adverse event was based on patient harm, additional medical intervention.Explanation and rationale: an investigation was made of the same material and error pattern in another complaint.The soldered joint is made according to a work instruction and the solder is applied inside the ceramic part gk384200.As the soldered joint is hidden and cannot be checked visually, the joint of gk384202 and gk384200 is tested at 100% by a deduction test with 20n, this test is used to verify the quality of the soldered joint.On this basis the products are released by manufacturing.As this test is done 100% on the whole batch, the products have been delivered by the manufacturing department within the required specification.Conclusion/preventive measures: based upon the above mentioned investigation results, a definitive root cause for the reported issue could not be established.All electrodes are subjected to a 100% mechanical test before delivery, so a production-related error can be ruled out.
Event or Problem Description
Investigation complete.

• Brand Name: CERAMIC ELECTRODE TIP L-HK F/GK372R
• Common Device Name: ELECTRODES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17773802
• Report Number: 2916714-2023-00088
• Device Sequence Number: 7491422
• Product Code: GEI
• UDI-Device Identifier: 04038653172504
• UDI-Public: 4038653172504
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/07/2023
• Report Date (Section F): 09/19/2023

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: 08/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/07/2023
• 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: 09/19/2023