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

Model Number EK002SU

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2023

Event Type  malfunction  

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 ga330 - acculan 4 drill and reamer.According to the complaint description, the product idles and overheats.Patient harm was unknown.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: for this particular complaint, the device was not received.For the investigation, we received original packed products from the customers.The root cause analysis was performed as part of product safety case (b)(4).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.No similar incidents have been filed with products from this batch.The current failure rate is within the risk analysis and therefore acceptable; probability was 2-5(5) and severity was 1(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: 16271656
• MDR Text Key: 308492611
• Report Number: 9610612-2023-00025
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/16/2023

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: EK002SU
• Device Catalogue Number: EK002SU
• Device Lot Number: 52795814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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