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

Model Number PL574T

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2020

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 pl574t - challenger ti-p sm-ligat.Clips 12 cartr.According to the complaint description, the cartridge jammed and latch was broken during surgery.The clip magazine was jammed from second shot.And probably latch of cartridges was broken and lost in the thoracic cavity and there might be a possibility remaining in the patient's body.Patient was safe.A broken fragment remained in situ.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.There is the possibility that the broken off latch was damaged due to an improper removal out of the primary sterile package or improper inserting of the cartridge.If the cartridge is engaged not completely or was damaged during inserting, 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 too fast application could also lead to wrong positioned clips and a clip jam.A too fast application and / or the clip jam could also lead to a detached cartridge.Based upon our historically grown product experience and due to different simulation regarding a too fast application or a cartridge which is engaged not completely, this leads to the described errors.Possibly a damaged clip applicator due to a deformed push rod or something similar could be another cause for wrong positioned clips or clip jam.If further investigations are required, the product should be provided for examination.Furthermore according the instruction for use (ifu) certain points must be observed.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.The exact cause cannot be determined.A product safety case (psc) will be requested.

Event Description

The adverse event is filed under aag reference (b)(4).

• 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: 11204909
• MDR Text Key: 227946792
• Report Number: 9610612-2020-00999
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention