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 site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap ag that a challenger ti-p ligature clips device was used during a pancreatectomy procedure performed on (b)(6) 2020.According to the complainant, the ligature clips consecutively fired without being triggered.The event led a procedural delay of approximately five (5) to ten (10) minutes.No known 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 malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Up to now, product was not provided.Therefore, no pictorial documentation possible.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.Without the product, an exact cause cannot be determined at this moment.Additional information / results after received product will be submitted in a supplemental report.
Additional Manufacturer Narrative
Investigation results: visual investigation: we made a visual inspection of the products.Here we found wrong positioned clips.Additionally we discovered deformed slider sheets and deformed latches of the slider sheet.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.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.Based upon the investigations results a capa is not 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: 10566542
• Report Number: 9610612-2020-00551
• Device Sequence Number: 19573956
• Product Code: FZP
• UDI-Device Identifier: 04046963356057
• UDI-Public: 4046963356057
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 04/01/2021

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: 09/19/2024
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52549881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 03/05/2021
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 11/18/2020; 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PL604R - MULTIF.CLIP APPL.TI-P 5/310MM F/SM-CLIPS; PL604R - MULTIF.CLIP APPL.TI-P 5/310MM F/SM-CLIPS