MAUDE Adverse Event Report: AESCULAP AG DISP.UNIV-SEALING UNIT F/10/12MM TROCARS; ACCESS / TROCARS

Model Number EK002SU

Device Problem Device Damaged by Another Device (2915)

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

Event Type  Injury  

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 ek002su - disp.Univ-sealing unit f/10/12mm trocars.According to the complaint description, at the end of a procedure, small parts of the universal sealing unit were found to have broken off.It was noted that there had been frequent leakage during the surgery.An additional medical intervention was required.The pieces were retrieved from the patient's abdomen.The adverse event / malfunction is filed under aag reference 100031302/400567788.Associated medwatch reports: (b)(4) (9610612-2022-00255) ek002su, (b)(4) (9610612-2022-00270) ek002su, (b)(4) (9610612-2022-00271) ek002su.

Event Description

Associated medwatch reports: 400565385 (9610612-2022-00255) ek002su.400567787 (9610612-2022-00270) ek002su.400567788 (9610612-2022-00271) ek002su.

Manufacturer Narrative

Investigation results: for the investigation, we received original packed products from the customers.The root cause analysis was performed as part of product safety case (psc) 2022-082.In summary, the cause is a combination of defective parts.First, the ek002250s are not fluorinated to specification, and second, the ek002252s are not dimensionally accurate or true to shape.If the ek002250s are fluorinated correctly, small micro lines can be found on the surface.If fluorination is not correct, these lines are not visible.These failures can lead to high friction between the inserted dilator or instrument and cause the internal parts (ek002250 and ek002252) to jam and detach.Batch history review: manufacturing-related defects were found that were not detected by the tests during the manufacturing process.The tests will be reviewed and adjusted accordingly.There were 6 similar incidents filed with products from this batch.The current failure rate is within the risk analysis and therefore acceptable; probability was 2-3(5) and severity was 3(5).Conclusion and measures / preventive measures: based upon the investigation results, the root cause is most probably manufacturing- related.Corrective actions will be documented in the psc.The supplier will revise the fluorination process, a 100% haptic test will be implemented after fluorination.In the medium term, the parts will be separated after fluorination.Furthermore, the tool for ek 002252 will be replaced.

• Brand Name: DISP.UNIV-SEALING UNIT F/10/12MM TROCARS
• Type of Device: ACCESS / TROCARS
• 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: 15363538
• MDR Text Key: 299309798
• Report Number: 9610612-2022-00271
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EK002SU
• Device Catalogue Number: EK002SU
• Device Lot Number: 52759372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention