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

Model Number	GK384R
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
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 that there was an issue with gk384r - ceramic electrode tip l-hk f/gk372r.According to the complaint description, that the ceramic electrode tip had become detached inside a patient during an operation.It is not known if the device fragment was recovered.An additional medical intervention was necessary.Additional information was not available.Additional patient information is not available.The adverse event malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Correction: update to b5.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.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, a capa is not necessary.
Event or Problem Description
The adverse event, malfunction is filed under aag reference (b)(4).Update: the device was noted, at the beginning of the laparoscopic cholecystectomy to be missing the cauterization hook.X-rays were completed to determine, if the hook was retained in the patient.Which caused a delay in closure.There was no evidence, that the item was retained in the patient.The device was forwarded to the hospital's (b)(6).

• Brand Name: CERAMIC ELECTRODE TIP L-HK F/GK372R
• Common Device Name: ELECTRODES (LAPAROSCOPIC SURGERY)
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11561424
• Report Number: 9610612-2021-00219
• Device Sequence Number: 19572140
• Product Code: GEI
• UDI-Device Identifier: 04038653172504
• UDI-Public: 4038653172504
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/12/2021
• 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