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

Model Number GK384R

Device Problem Break (1069)

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

Event Date 08/30/2023

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 l hook was seen laying in the patient, it was not adhered to anything or impeding anything.This event occurred during the surgery when the suction was performed.A grasper was used to extract the tip, and when the apparatus that houses the tip was removed from the shaft of the instrument it broke into two separate pieces.The hook itself as well as one half of the apparatus was able to be retrieved, however the second half was discarded with the sharps and unable to be retrieved.Additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.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.

Event Description

Update: this event occurred during a laparascopic procedure.An unspecified surgical delay was noted.

Manufacturer Narrative

Additional information/correction: b5 - event clarification.D9 - product return date.H3 - evaluation.H6 - codes updated.Investigation results: investigator carried out the pictorial documentation visually and microscopically.The hook is broken off of the product.Device 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.Investigation results were based on examination of the same material from another complaint.The assessment for reportability for this adverse event was based on patient harm, additional medical intervention.Explanation and rationale: an investigation was made of the same material and error pattern in another complaint.The soldered joint is made according to a work instruction and the solder is applied inside the ceramic part gk384200.As the soldered joint is hidden and cannot be checked visually, the joint of gk384202 and gk384200 is tested at 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.Conclusion/preventive measures: based upon the above mentioned investigation results, a definitive root cause for the reported issue could not be established.All electrodes are subjected to a 100% mechanical test before delivery, so a production-related error can be ruled out.Based upon the investigation resulst, a capa is not necessary.

• 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: 17817469
• MDR Text Key: 324253040
• Report Number: 9610612-2023-00213
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 10/24/2023
• 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
• Patient Outcome(s): Required Intervention