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

Model Number PL574T

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2021

Event Type  Injury  

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 pl574t (lot 52491850) fell in patient's abdomen.Additionally, massive problems with applier pl604.Functionality of the applier checked on site, no error could be found.Again pointed out all the application handling errors.Broken parts completely removed.Another cartridge was used.Everything worked fine.Sister told that is was difficulty to fit the cartridge on the shaft/ applier.Type of surgery: ovarpexy.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Involved components: pl520r- challenger ti-p handle -52491850.Pl522r - shaft compl.D:5mm l:310mm - 52491850.

Event Description

Additional information received: broken parts completely removed.Another cartridge was used.Everything worked fine.The adverse event is filed under aag reference (b)(4).Involved components: pl520r- challenger ti-p handle -52491850 pl522r - shaft compl.D:5mm l:310mm - 52491850.

Manufacturer Narrative

Investigation results: the products were lost during internal transport.Therefore, a thorough investigation is not possible.An analysis according to the photos provided by customer is not possible.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.T 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.Based on the information due to sap: "is was difficulty to fit the cartridge on the shaft/ applier." there is the possibility that the cartridge was engaged not completely.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 clip jam could also lead to a detached cartridge.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.The cause could be a damage or not performed maintenance.Furthermore according the instruction for use (ifu) certain points must be observed.Conclusion and root cause due to the current deviation and according to explanation and rationale, the root cause of the problem is most probably maintenance and usage-related.The exact cause could not be determined.Corrective action based upon the investigations results a product safety case (further internal investigation) initiated.

• 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: 11288092
• MDR Text Key: 234266921
• Report Number: 9610612-2021-00049
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2024
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52491850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PL520R - 52491850; PL520R - 52491850; PL522R - SHAFT COMPL.D:5MM L:310MM; PL522R - SHAFT COMPL.D:5MM L:310MM
• Patient Outcome(s): Required Intervention