MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LAPAROSCOPIC SURGERY

Model Number PL572T

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

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

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

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 clip.It was reported that the clip magazine could not be attached to the applying forceps.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.During the visual inspection of the product, we found a broken latch.The surface of the breakage does not show any anomalies.It was found that one clip is missing and there are still 11 clips in the magazine.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.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.

Event Description

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

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10509950
• MDR Text Key: 207343749
• Report Number: 9610612-2020-00502
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52596627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1