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

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a challenger ti-p sm-ligat.Clips 12 cartr.(part # pl574t) was used during a laparoscopic hepatectomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the cartridge detached.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

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 have been checked for the available lot number and were found to be according to our specifications 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.According to the investigation results there is no capa request necessary.

Event Description

Update: this case is associated wit following mdr number 9610612-2021-00500 (400518301 pl574t), 9610612-2021-00539 (400518302 pl574t), 9610612-2021-00501 (400518303 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
• MDR Report Key: 12166069
• MDR Text Key: 261487904
• Report Number: 9610612-2021-00500
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04046963356057
• UDI-Public: 4046963356057
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1