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

Model Number GK384R

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product gk384r - ceramic electrode tip l-hk f/gk372r.According to the complaint description, the tip of a laparoscopic hook electrode snapped off during a surgery into the patient's abdomen.The tip had snapped off from the neck of the device during a laparoscopic cholecystectomy.A disposable hook electrode was used instead to complete the procedure.The broken tip was retrieved, and the parts were confirmed to be complete.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Additional information was not provided nor available.The adverse event / malfunction is filed under aesculap ag reference no.(b)(4).

Manufacturer Narrative

Additional information: h3 - yes, evaluation.H6 - codes updated.Investigation results: a visual and microscopic investigation was performed.The ceramic insulation/body was in a perfect condition, without cracks or chipped- off parts.The surface of the broken electrode is dull and dark, a sign that it has been used many times.The fracture surface on the body and the fracture surface on the electrode are typical of an overload fracture.No parts are missing.Batch history review: based on the production date of april 2019, identification of four batches for this period was possible.This concerns the batches 52513696; 52514849; 52516502 and 52519210.There was no evidence of manufacturing problems or other deviations in any recording of the batches mentioned above.There were no further complaints from any of the batches mentioned above.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: a definitive root cause for the problem cannot be determined.The fracture surface shows no signs for 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.Based upon the investigation results, a capa is not required.

• Brand Name: CERAMIC ELECTRODE TIP L-HK F/GK372R
• Type of Device: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18894420
• MDR Text Key: 337549980
• Report Number: 9610612-2024-00023
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GK384R
• Device Catalogue Number: GK384R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention