MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LIGATION / VESSEL CLIPS

Model Number PL569T

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/09/2020

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 pl569t - ligating clips m/l 12/box.According to the complaint description, the applicator was planned to be used to place clips for section of the sigmoid vessel.During the laparoscopic surgery (resection of the sigma for complicated diverticular disease), when placing the clips on sigmoid vessel, dm showed malfunction with fall of 2 clips and of the loader.Material was removed from the trocar without intraoperative problems.The applicator was replaced and it was managed to close the vessel at the third cartridge.Additional information was not provided nor available / was not available.The / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report, the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.In the event, that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.

Event Description

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

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11088450
• MDR Text Key: 227799548
• Report Number: 9610612-2020-00943
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K962493
• 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: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52642020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1