MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LIGATION / VESSEL CLIPS

Model Number PL572T

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907); Ejection Problem (4009)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/07/2020

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 ligature clips.According to the complaint description the clips fell into the body during surgery.Clips got stuck in the second and third shot.No infection was reported.According to the information available a fragment of the device remained in situ.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: cartridge #1: no deviation found.Cartridge #2: proximal latched broken off, fragment not available.Sliding sheet deformed, pressed together, most likely by closing jaws during application.Cartridge #3: distal end of sliding sheet kinked, probably due to pressure applied on the tissue during application.Therefore, the clip and the sliding sheet have been blocked and hence the sliding sheet kinked.Cartridge #4: the latches of the slider sheet are kinked, probably due to pressure applied on the tissue during application.Therefore, the clip and the sliding sheet have been blocked and hence the sliding sheet kinked.Packaging: opened, no trouble 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 there is one similar complaints against the same lot number(s).The review of risk assessment revealed that the overall risk level (severity 3(5) 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 upon the investigations results there is capa is not necessary.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10620104
• MDR Text Key: 209599489
• Report Number: 9610612-2020-00625
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2024
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52513795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1