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

Model Number PL574T

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

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 challenger clips.It was reported that the user found the whole cartridge detached from the pneumatic clip applier when the surgeon try to fire the clip; and a plastic sheet about 0.1mm x 0.2mm is missing from the cartridge after detailed inspection of the cartridge.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag (b)(4).

Manufacturer Narrative

Investigation results: up to now, the cartridge is not available for investigation.Only photos are available from the customer in reference to the photos the lateral web is visible damaged.The device quality and manufacturing history records have been checked for the lot number (52463971) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.No product available and therefore it is hardly possible to determine an exact conclusion and root cause.It appears that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.According to the quality standard and the device history records files a material defect and production error can be excluded.There is the possibility for a too fast application by an improper handling.This led to a jumped off cartridge.The visible damaged lateral webs could have caused due the jumping off.Based upon our historically grown product experience and due to different simulation regarding a too fast application, this leads to the described error.There is also the possibility that the cartridge has not been mounted correctly and during application the cartridge jumped off.If the cartridge is engaged not completely or was damaged during inserting, there is an impairment of product functionality.This could also led to the described error.Possibly a damaged clip applicator due to a deformed push rod or something similar could be another cause for the described error.A capa was not initiated.

• 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: 9251470
• MDR Text Key: 178633953
• Report Number: 9610612-2019-00743
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52463971
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1