MAUDE Adverse Event Report: AESCULAP AG CERAMIC ELECTRODE TIP L-HK F/GK372R; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	GK384R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
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 that a ceramic electrode tip (part # gk384r) was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2020.The physician reported that the tip of the l hook broke off during surgery.According to the complainant, approximately midway through the procedure, while the surgeon cut and moved tissue to access the duct and artery that required clipping, the tip of the l hook detached into the patient.Although the tip was retrieved from the patient, an abdominal x-ray was performed.Reportedly, the x-ray displayed a metal fragment within the patient's abdomen.A search of the surgical site was performed, but the fragment was not able to be located.The device is not currently available to be returned to the manufacturer for evaluation.The surgery was delayed approximately one (1) hour.No known patient complications were reported as a result of this adverse event.The adverse event / malfunction is filed under aag reference (b)(4).
Event or Problem Description
Information received via mw # (b)(4): patient data: female, 25 years old.The surgeon removed device from cautery holster and used laparoscopically.The tip was immediately noted to be missing.The wound and field were explored and broken tip was found inside the holster (outside the patient's body).The parts were compared to a complete l-hook and appeared to match.An x-ray was taken to verify that all pieces had been removed and there was a very small fragment visible on the x-ray; it was not verified if this was part of the tip or fragment because it was not located at a site that had been operated on (previously during surgery).
Additional Manufacturer Narrative
Investigation results: to date there is no device available for investigation.Therefore, no investigation possible.The provided pictures can not be used for a detailed investigation.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 current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: on the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.For further investigations we need the product for examination.Based on the investigations and results of the 8d report a capa is not necessary.

• Brand Name: CERAMIC ELECTRODE TIP L-HK F/GK372R
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10764688
• Report Number: 9610612-2020-00758
• Device Sequence Number: 1086397
• Product Code: GEI
• UDI-Device Identifier: 04038653172504
• UDI-Public: 4038653172504
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: GK384R
• Device Catalogue Number: GK384R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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