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

Model Number	PL579T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, the clip dartridge fell into patients´s body.When the main body shaft was pulled out from the trocar, the cartridge fell into the patient's body.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Updated h6: codes.Investigation results: visual investigation: the product arrived in a clean status with a deformed slider sheet.The investigation was carried out visually and microscopically.Here we detected a deformed slider sheet, scratches and marks on the housing.According to the quality standard a material defect and a production error can be excluded.There are no hints of a pre-damage or similar.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.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence3(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results the root cause of the problem is most probably usage related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a product safety case (b)(4) was initiated.Any action regarding capa will be addressed with this case.

• Brand Name: CHALLENGER TI-P ML-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: 11574636
• Report Number: 9610612-2021-00227
• Device Sequence Number: 4455622
• Product Code: FZP
• UDI-Device Identifier: 04046963356040
• UDI-Public: 4046963356040
• 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): 09/21/2021

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 Expiration Date: 07/14/2025
• Device Model Number: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52621460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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