MAUDE Adverse Event Report: AESCULAP AG ENDOSCOPIC MYOMA FIXATION INSTRUMENT; HANDHELD PRODUCTS & LIGATION

Model Number PL430R

Device Problem Break (1069)

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

Event Date 06/27/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should additional information / investigation results become available, a supplemental report will be submitted.

Event Description

This report is submitted in reference to mw5119092.It was reported to aesculap inc.That an endoscopic myoma fixation instrument (material # pl430r) was used during a procedure performed on (b)(6) 2023.According to the complainant, during the surgery, the tip of myoma screw broke.Fragments detached into the patient, but all were successfully retrieved.The complaint device was returned to the manufacturer for evaluation.Patient harm was unknown.Additional information was requested, but has not yet been made available.The adverse event/malfunction is filed under aic reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should additional information / investigation results become available, a supplemental report will be submitted.

Event Description

This report is submitted in reference to mw5119092.It was reported to aesculap inc.That an endoscopic myoma fixation instrument (material # pl430r) was used during a procedure performed on (b)(6) 2023.According to the complainant, during the surgeyr, the tip of myoma screw broke.Fragments detached into the patient, but all were successfully retrieved.The complaint device was returned to the manufacturer for evaluation.Patient harm was unknown.Additional information was requested, but has not yet been made available.The adverse event/malfunction is filed under aic reference (b)(4).

Manufacturer Narrative

Investigation result: investigator carried out the pictorial documentation visually and microscopically.The instrument is in a worn condition, the working end of the device has fractured about 40mm after the distal end, the fragment is present for examination.The fracture surface of shows no abnormalities like blowholes of foreign particle inclusions.Due to the small dimension/diameter of the device, a detailed fracture surface analysis is difficult.Due to that circumstance there are no clear hints regarding arrestlines (hints for fatigue fracture) or clearly signs of a forced fracture.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.The current failure rate is within the risk analysis and therefore acceptable according to according to din en iso 1497; severity was 3(5) and probability 1(5).Conclusion and preventive measures: based upon the above mentioned investigation results, a definitive root cause for the reported issue could not be established.Based upon investigation results, a capa is not necessary.

Event Description

Investigation complete.

• Brand Name: ENDOSCOPIC MYOMA FIXATION INSTRUMENT
• 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: 17491984
• MDR Text Key: 320765391
• Report Number: 2916714-2023-00083
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 04038653347957
• UDI-Public: 4038653347957
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2023,09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL430R
• Device Catalogue Number: PL430R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2023
• Distributor Facility Aware Date: 07/12/2023
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2023
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 07/12/2023; 07/12/2023
• Supplement Dates FDA Received: 08/09/2023; 09/26/2023
• Was Device Evaluated by Manufacturer?: No
• 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