MAUDE Adverse Event Report: AESCULAP AG MONOPOLAR HANDLE WITH RATCHET; HANDHELD PRODUCTS & LIGATION

Model Number PO959R

Device Problems Energy Output Problem (1431); Excessive Heating (4030)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was an issue with po959r - monopolar handle with ratchet.According to the complaint description, the device caused a burn.During a gallbladder surgery, the instrument was placed on the (obese) patient in such a way that the handle on the red ring of the rotating star made contact with the abdominal surface.The patient experienced temporary impairment.Additional patient information is not available.The malfunction 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

It was reported that there was an issue with po959r - monopolar handle with ratchet.According to the complaint description, the device caused a burn.During a gallbladder surgery, the instrument was placed on the (obese) patient in such a way that the handle on the red ring of the rotating star made contact with the abdominal surface.The patient experienced temporary impairment.Additional patient information is not available.The malfunction 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/correction: after reviewing the evaluation, the complaint has been re-assessed and this event is considered no longer reportable for the following reason: the investigation results revealed that a product-related failure can be excluded.H6 codes - updated investigation: in the first step we made a visual inspection of all three handles.We inspected the surfaces in search of visible burnings or charring.None of the instruments shows such defects which were hints for an insulation defect.In the next step we performed out a high voltage test (testing time 30 sec.Testing tension 2,5 kv).All instruments passed this test without deviations.At last we tested the mechanical functions (ratchet and shaft locking / release).Also these functions are without deviation at all three instruments.In order for such a problem as described to arise, several circumstances must occur: - high moisture load right into the instrument -instrument placed direct on the patient - start of the rf- current (button / foot- switch) if the humidity is too high, creepage distances from live parts to the surface of the instrument can occur.A metal piece in the undercut of the handle is noted, which has full rf potential during activation of the generator.Normally it is not possible to touch this point directly, but if there is too much moisture at this point, creepage paths can arise.For this reason, the instructions for use (ifu) also explicitly point out not to place these handles / instruments next to or on top of the patient.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 (severity 2(5) x probability of occurrence 2(5)) 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 necessary.

• Brand Name: MONOPOLAR HANDLE WITH RATCHET
• 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: 13621283
• MDR Text Key: 286273107
• Report Number: 9610612-2022-00058
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K940936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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 Operator: Health Professional
• Device Model Number: PO959R
• Device Catalogue Number: PO959R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/19/2022
• 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