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

Model Number PL572T

Device Problems Material Fragmentation (1261); Mechanical Problem (1384); Device Fell (4014)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2020

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 a ligature clip.According to the complaint description the metal part of the device came off.No infection was reported.There was no patient harm.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under (b)(4) reference (b)(4).

Event Description

The malfunction is filed under aag reference: (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually and microscopically.Nine of twelve clips remained in the cartridge.The sliding sheet is dislocated and deformed.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 a 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: 10478311
• MDR Text Key: 205489216
• Report Number: 9610612-2020-00474
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 08/26/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1