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.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 that there was an issue with a ceramic electrode tip (part # gk384r) was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2021.According to the complainant, near the end of the procedure, the inner metal post detached.Reportedly, while the surgeon was removing the gallbladder from the liverbed, the electrode tip separated into two (2) pieces.The fragments detached into the patient, and were retrieved from the surgical field using a laparoscopic grasper.There was less than a five minute delay due to the incident.The surgery was completed using another aesculap monopolar instrument.The complaint device was available to be returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference xc (b)(4).
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Investigation failure description up to now no product available.Therefore a failure description at the product is not possible.Investigation up to now, no product available.Therefore a failure description at the product is not possible.Pictorial documentation up to now, no product and no picture are available.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.Conclusion and root cause no product available and therefore it is hardly possible to determine an exact conclusion and root cause.The exact cause cannot be determined.Corrective action there is no capa necessary.
Additional Manufacturer Narrative
The device was returned to the manufacturer and evaluated.Leading device: reference code gk384r.Device name ceramic electrode tip l-hk f/gk372r.Serial number n/a.Batch number unknown.Manufacturing date 01.11.2020.Failure description: the product arrived in a clean condition with a broken off, part.Gk384200 is separate from part gk384800.Investigation: the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.2000024840) and digital-camera "panasonic dmc tz8".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.Explanation and rationale: 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.Conclusion and root cause: due to the current deviation and according to explanation and rationale, the root cause of the problem is most probably usage-related.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa request necessary.
Event or Problem Description
No updates.

• 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: 11703967
• Report Number: 2916714-2021-00065
• Device Sequence Number: 17055507
• 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,Followup
• Report Date (Section B): 07/08/2021
• Report Date (Section F): 04/21/2021

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?: Yes
• Date Returned to Manufacturer: 04/23/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/07/2021; 07/08/2021
• 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: 04/21/2021