MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.; LIGATION / VESSEL CLIPS

Model Number PL579T

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/21/2021

Event Type  Injury  

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 pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, during use a prostatectomy with a robot cartridge which jumps after 2 clips placed.Change to another bar, presenting the same problem.A total of 6 cartridge used and clamp changed once.Single-use forceps test: failed because too short.Clinical consequences observed: loss of the cartridge and metal clips in the patient's abdomen.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00077 (400500906 + pl579t), 9610612-2021-00076 (400500905 + pl579t).

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.2000024840) and the digital-camera panasonic dmc tz8.We made a visual inspection of the products.Here we detected a broken off nose, scratches, wrong positioned clips, bent latches and a deformed slider sheet.Also we discovered a clip jam.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 one similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: according to the quality standard and dhr files a material defect and a production error can be excluded.There are no hints of a pre-damage or similar.Furthermore, it was unclear in the facts of the case if the ifu was followed regarding changing the co² cylinder after each clip magazine.Investigations also leads to the assumption that the co² cylinder was not changed after each new insertion of a titanium clip cartridge.This could lead to the described error.Possibly a damaged clip applicator due to a deformed push rod or something similar could be another cause for the mentioned deviation.There is also the possibility for an improper inserting of the titanium clip cartridge.Based upon the investigations results a capa is not necessary.Associated medwatch-reports: 9610612-2021-00076, 9610612-2021-00077, 9610612-2021-00163.

• Brand Name: CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11322852
• MDR Text Key: 233548306
• Report Number: 9610612-2021-00078
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52641394
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention