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

Model Number PL579T

Device Problem Device Damaged by Another Device (2915)

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

Event Date 10/12/2020

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 100026644/400489676.Associated medwatch-reports: 9610612-2020-00769 (400489677 pl574t).

Manufacturer Narrative

Reference code pl579t, device name challenger ti-p ml-ligat.Clips 12 cartr, serial number: n/a, batch number: 52625554, udi device identifier: (b)(4), udi production identifier: 52625554, basic udi-di: (b)(4), unit of use udi-di: (b)(4), manufacturing date 31.08.2020.The clip cartridge, as well as the co2 cartridge was available for investigation decontaminated.Failure description: the sliding sheet is deformed at the latches and at the proximal end.Only one clip remained in the clip cartridge.The co2 cartridge is opened.Investigation: investigation was carried out visually and microscopically.The sliding sheet is deformed at the first and second latches and at proximal end.Most likely caused by overload situation, during application.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.Explanation and rationale: according to the quality standard, a material defect and production error can be excluded.A usage related error cannot be excluded, e.G., due to improper handling or an overload situation.Based upon our historically grown product experience, and due to different simulations regarding an insufficient inserting of the cartridge or a too fast application of the clips, this could be one possible root cause of the described failure.Malfunctions can be caused by incorrect assembly sequence.The correct order of assembly must be observed.Furthermore, a damaged applicator could be the reason for an insufficient transport of the clips within the cartridge.Conclusion and root cause: due to the current deviation and explanation above, the root cause of the problem is most probably usage related.Corrective action: a capa is not 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: 10751729
• MDR Text Key: 213934936
• Report Number: 9610612-2020-00770
• 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: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52625554
• 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