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

Model Number PL574T

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information or investigation results are provided, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with challenger ti-p sm-ligat.Clips 12 cartr.According to the complaint description, multiple times it was not possible to fire after loading cartridge.Only able to fire first 1-5 clips, thereafter, unable to fire the rest of the remaining clips.One cartridge dislodged form shaft.There was no patient harm; the malfunction occurred during an unspecified surgery.Additional information was not provided.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: pl522r, shaft compl.D:5mm l:310mm - 52614422.Pl520r, challenger ti-p handle.

Manufacturer Narrative

Investigation results: visual investigation: handle and shaft have been tested according the test plan successfully.No deviations could be found at the components functional tests were carried out successfully.The error pattern could not be readjusted as described.In particular, it was not possible to simulate that only 1-5 clips were applied as claimed.A gas loss can be excluded as the leak test of the handle was passed.The detachment of a cartridge from the shaft is probably related to an empty co² cartridge.Therefore, the sliding sheet of the cartridge was deformed distally by closing jaws.This is an indication that the slider could not return to its original position after clip transfer.No manufacturing or material related error could be found at the components in question.To avoid malfunctions, the correct order of assembly must be observed 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.Based upon the investigations results 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: 10534857
• MDR Text Key: 206957474
• Report Number: 9610612-2020-00504
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 400485043 - CHALLENGER TI-P HANDLE; PL522R - 52614422; 400485043 - CHALLENGER TI-P HANDLE; PL522R - 52614422