MAUDE Adverse Event Report: AESCULAP AG SHAFT ONLY F/MODULAR MONOPOL.ELECTR; REUSABLE INSTRUMENTS

Model Number GK370P

Device Problem Arcing of Electrodes (2289)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

The product was sent to the production department for the subject matter expert analysis.The results are as follows: we have no indication for a production related error.We detected that the tip of the shaft was damaged.It could be possible that liquid had gotten between the insulation tube and the hook electrode during the operation.The liquid then conducted the current.This is known as capillary action.It is important that the product does not run in continuous load.For safe handling and preparation of the product, please note the points in the instructions for use (ifu).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 review of risk assessment revealed that the overall risk level ((3)5 severity x (2)5 probability of occurrence) according to din en iso 14971 is still acceptable.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.Based on the investigation results a capa is not required.

Event Description

It was reported that there was an issue with gk370p - shaft only f/modular monopol.Electr.According to the complaint description, sparks came out near hook electrode.During use with vio30w, a spark came out from the root near the fitting of the hook electrode.According to the test results from a hospital scan, only the l-shaped non-insulated part at the tip makes noise and is insulated, but that is exactly where the sparks came out.Observation with a loupe showed that the hook was scratched, but no peeling of the insulation was found, and the deformation of the tip of the insulation part of the handle was caused by this spark.(inspected before use every time) there was no described patient harm.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch reports: gk370p (9610612-2022-00282) (b)(4).Involved components: gk373r - inner tube w/handle for gk372r (b)(4).Gk384r - ceramic electrode tip l-hk f/gk372r (b)(4).

• Brand Name: SHAFT ONLY F/MODULAR MONOPOL.ELECTR
• 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: 15498136
• MDR Text Key: 305155355
• Report Number: 9610612-2022-00282
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: GK370P
• Device Catalogue Number: GK370P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: GK373R - INNER TUBE W/HANDLE FOR GK372R.; GK384R - CERAMIC ELECTRODE TIP L-HK F/GK372R.