MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; CLIP, IMPLANTABLE

Model Number	PL574T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a challenger ti-p ligature clips device was used during a procedure performed on (b)(6) 2020.According to the complainant, the ligature clips cartridge detached from the shaft.A replacement device was used to complete the procedure.No patient complications occurred as a result of this event.Additional information has been requested, but has not yet been received.No patient details were made available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
No deviation could be found at the cartridge provided.According to the quality standard, a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation.Based upon our historically grown product experience and due to different simulations regarding an insufficient inserting of the cartridge or a too fast application of the clips, this could be one possible root cause of the described failure.Malfunctions can be caused by incorrect assembly sequence, the correct order of assembly must be observed.According to the 8 d report no capa is necessary.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10566856
• Report Number: 9610612-2020-00561
• Device Sequence Number: 2963041
• 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): 11/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2025
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52600083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1