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

Model Number PL572T

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing side: we received a complaint about intraoperatively malfunctions of ligature clips.No product for investigation available.According to the available information, there were no negative consequences for patient.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers 52551842 and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available it is not possible to determine a possible root cause for the failure.Rationale: without a product an exact determination of root cause is not possible.Based on the quality standard and the device history records, a material or production related error can be excluded.Therefore, the root cause of the error is most probably usage or maintenance of the applier-shaft related.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

Event Description

It was reported that there was an issue with ligature clips.According to the complaint description: "the clips doesn't close well, they detached from the barrette and fall into the patient's stomach.Barrettes deformed." no consequence for patient, the part has been recovered.A medical intervention was not necessary.There was no surgery delay.The malfunction is filed under (b)(4).

Manufacturer Narrative

New information has been added to b5: associated medwatch reports evaluation previously reported.

Event Description

New associated medwatch reports: 9610612-2019-00951 (400460415 pl522r); 9610612-2019-00952 (400460416 pl510r); 9610612-2019-00973 (400461699 pl522r); 9610612-2019-00974 (400461700 pl522r); 9610612-2019-00975 (400461701 pl522r); 9610612-2019-00976 (400461702 pl522r); 9610612-2019-00977 (400461703 pl522r).

• 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: 9528472
• MDR Text Key: 179470241
• Report Number: 9610612-2019-00859
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• 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: 52551842
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1