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

Model Number EK002SU

Device Problems Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

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 product disp.Univ-sealing.It was reported that the valve inside the seal was damaged and dropped into the body.The damaged valve was recovered and the patient was not affected.There was no patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually and microscopically.No deviations could be found on the valve housing, but a fragment of the sealing unit was provided separately.After disassembling the valve, the broken part was found.The damage was most likely caused by a sharp or pointed instrument when inserted into the trocar.The area of breakage did not show any unusual structural change, no pore inclusions or foreign bodies could be found.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) 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 upon the investigations results there is capa is not necessary.

Event Description

The malfunction is filed under aag reference 400476150.

• Brand Name: DISP.UNIV-SEALING UNIT F/10/12MM TROCARS
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10283228
• MDR Text Key: 204977203
• Report Number: 9610612-2020-00260
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1