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

Model Number PL574T

Device Problem Unintended Ejection (1234)

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

Event Date 06/19/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation results.Visual investigation: the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.The investigator made a visual inspection of the products.Here they detected a broken off nose, wrong positioned clips, bent latches and deformations on the slider sheet.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.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.Investigations lead to the assumption that the cartridge is not engaged completely, there is an impairment of product functionality.This could led to deformed latches of the slider, to wrong positioned clips and a clip jam.A clip jam could also lead to a detached cartridge.Furthermore a too fast application of the cartridge can also led the clip jam and deform the slider sheet.Based upon our historically grown product experience and due to different simulation regarding a cartridge which is engaged not completely, this leads to the described errors.If the shaft / applier no longer conforms to the specification, this can also result in an incorrect engaged cartridge.Based upon the investigations results a capa is not necessary.

Event Description

It was reported that there was an issue with pl574t - challenger ti-p sm-ligat.Clips 12 cartr.According to the complaint description, the cartridges were detached during use for laparoscopic hepatectomy.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).This case is associated with follow mdr numbers 9610612-2021-00500 ((b)(4) + pl574t), and 9610612-2021-00501 ((b)(4) + pl572t).

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12320369
• MDR Text Key: 266764648
• Report Number: 9610612-2021-00539
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 52622401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1