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

Model Number PL574T

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2023

Event Type  Injury  

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 detached.Clips had jammed before detachment of the cartridge.Cartridge then separated from the clamp and fell into the patient, where they were retrieved.An additional medical intervention was necessary.There was a surgical delay of 10 minutes.Additional information was not provided.The adverse event is filed under aag reference (b)(4).Involved components: 400588198 - pl520r/ challenger ti-p handle - lot unknown.400588199 - pl520r/ challenger ti-p handle - lot unknown.400588201 - pl522r/ shaft compl.D:5mm l:310mm - lot unknown.400588202 - pl522r/ shaft compl.D:5mm l:310mm - lot unknown.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Additional information/correction: b5 - lots for involved components updated.D10 - lots for involved components updated.H6 - codes.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.No investigation method could be applied, because: the complaint sample was not provided for investigation.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: due to a lack of data and without the product we cannot determine an exact conclusion and root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Conclusion and measures / preventive measures: based upon the investigation results a root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.A capa was initiated to further evaluate the root cause for various issues regarding the challenger system.

Event Description

Update: added lots number for involved components.The adverse event is filed under aag reference 100032378 (400587208).Involved components: 400588198 - pl520r/ challenger ti-p handle - lot 62493079.400588199 - pl520r/ challenger ti-p handle - lot 62537338.400588201 - pl522r/ shaft compl.D:5mm l:310mm - lot 62534255.400588202 - pl522r/ shaft compl.D:5mm l:310mm - lot unknown.

• 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: 16397442
• MDR Text Key: 309791930
• Report Number: 9610612-2023-00033
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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: 01/30/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PL520R - LOT 62493079; PL520R - LOT 62537338; PL520R - LOT UNKNOWN; PL520R - LOT UNKNOWN; PL522R - LOT 62534255; PL522R - LOT UNKNOWN; PL522R - LOT UNKNOWN; PL522R - LOT UNKNOWN
• Patient Outcome(s): Required Intervention