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

Model Number	PL574T
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem 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 parts of the device fell into the cavity.The magazine (pl574t) is jammed, causing it to fall into the body cavity and pin was damaged.In ldg, the first magazine (12 shots) was used up, and the second magazine was replaced, then magazine was jamed second shot.After that, when the handle was opened and closed in the body cavity, the magazine fell into the body cavity.At that time, the pin at the base broke and went missing in the body cavity.A 4,000cc intraperitoneal lavage was performed and the surgery was completed.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00212 ((b)(4)).
Additional Manufacturer Narrative
Investigation results: visual investigation: the products arrived in a clean status.One of them shows no visible deviations and the other have a broken off latch and a visible damaged slider sheet.The investigation was carried out visually and microscopically.Here we detected a broken off latch, a deformed slider sheet and fractures on the lateral webs.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 leads to the assumption that the cause for the mentioned deviation was caused by an improper handling.Based on the information described in sap there is the possibility that the co2 cartridge was not changed after insertion of the titanium clip cassette.This leads to the described deviation.If the co2 cartridge is not changed, the remaining oxygen quantity is too low to push the second titanium clip cassette.This could lead to the deformed slider sheet.A broken cassette latch can also lead to a detached titanium clip cassette.Based upon historically grown product experience and due to different simulation regarding a too fast application or a titanium clip cassette which is engaged not completely, this leads to the described errors.This points are also described in the instruction for use.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 two similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 3(5)) according to din en iso 14971 is still not acceptable.Therefore, the risk analysis has to be verified by r&d.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing, or design-related failure.A product safety case will be requested.Any action regarding capa will be addressed with this case.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00213 (400504842 - pl574t); 9610612-2021-00212 (400504843 + pl574t).

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Common Device Name: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11552797
• Report Number: 9610612-2021-00213
• Device Sequence Number: 14414018
• Product Code: FZP
• UDI-Device Identifier: 04046963356057
• UDI-Public: 4046963356057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52653757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention