MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; LAPAROSCOPIC SURGERY

Model Number PL574T

Device Problem Device Damaged by Another Device (2915)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation on going.Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with product challenger.According to the complaint description it was reported that the cartridge of clips does not fit correctly on the clamp, the plastic of the cartridge is damaged.The clip was closed on the blood vessel but got stuck in the cartridge.The clips then accumulated on top of each other in the cartridge.There was no patient harm reported.The procedure was a robotic-assisted prostatectomy.Additional patient information is not available; further details have been requested.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00770 (b)(4).(b)(4).

Manufacturer Narrative

Reference code (b)(4).Device name challenger ti-p sm-ligat.Clips 12 cartr.Serial number n/a.Batch number 52607471.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di (b)(4).Unit of use udi-di (b)(4).Manufacturing date 13.05.2020.The clip cartridge was available for investigation decontaminated.Failure description - the cartridge provided is no longer in its original shape, no clip is missing.Investigation - investigation was carried out visually and microscopically.The shape of the cartridge is deformed.Based upon our reprocessing experiments, this cartridge appears to be thermally reprocessed.Even the distal end is bent upwards.Therefore, the cartridge is no longer in the shape of delivery and no longer fitting to the shaft.It is no longer comprehensible if the cartridge has been reprocessed prior to surgery or after the attempt of mounting to the applier.Since the cartridges are delivered sterile, a processing was not foreseen.Batch history review - the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products were found to be according to our specifications valid at the time of production.There are no similar complaints against the same lot number with this error pattern.Explanation and rationale - the failure mentioned by the customer is no longer comprehensible since the cartridge has been reprocessed thermally.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Conclusion and root cause- same as above.Corrective action - no capa is necessary.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10751742
• MDR Text Key: 219565908
• Report Number: 9610612-2020-00769
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52607471
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1