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

Model Number GK384R

Device Problems Material Fragmentation (1261); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  Injury  

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 the hook became dislocated.There was no replacement device available during the coelioscopy.The patient was operated on again to remove the tip.A revision was required.Additional details had been requested; there was no information on the patient's condition.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h3 - evaluation, yes.Investigation results: a microscopic investigation of the received electrode was made.The ceramic insulation was in a perfect condition, without cracks or chipped- off parts.The electrode- body is in a proper condition, no dents or bending is visible.After that, the soldering surface on the tip of the electrode body was investigated.There, remnants of solder were found and the surface seemed to be evenly wetted.The tip of the electrode ("hook") was torn of the solder base.Batch history review: based on the production date of august 2020, we were able to identify two batches for this period.This concerns the batches 52628513; 52630602 and 52631578.There was no evidence of manufacturing problems or other deviations in any recording of the batches mentioned above.There have been 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, revision.Conclusion/preventive measures: a definitive root cause for the problem cannot be determined.The soldering surface at the tip of the electrode base was evenly covered with solder; there are no signs of irregularities during the soldering process.Unfortunately the fallen- off hook was not received for the investigation of the solder surface of the hook.The solder joint of each electrode is tested 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, 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: REUSABLE INSTRUMENTS
• 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: 18318492
• MDR Text Key: 330382616
• Report Number: 9610612-2023-00267
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• 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