MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LIGATION / VESSEL CLIPS

Model Number	PL572T
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	04/27/2021
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 ligature clip 12 mag.= 144 pcs (part # pl572t) was being tested prior to use during a procedure.According to the complainant, the clip was jammed.When checking the product in the presence of the agency, it was suggested that the plate might return slowly because there was a possibility of excessive gas leaking from the applier.No patient involvement.Although requested, additional information has not been made available.The malfunction is filed under (b)(4).Involved components pl575su - challenger ti-p co2-cartridge o - unknown.
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable.Investigation: visual inspection - the investigation was carried out visually and microscopically with a digital-camera.Here we found different clip jams.Batch history review - the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There was one similar complaint against the same lot number(s).The review of risk assessment revealed that the overall risk level was severity 2(5) x probability of occurrence was (b)(4); according to din en iso (b)(4), the rate was outside the allowed rate, and risk analysis has be to be verified by r&d.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.If the cartridge is engaged not completely, has not been mounted correctly or was damaged during insertion, there is an impairment of product functionality.A too fast application, damaged cartridge during inserting or a cartridge which is engaged not completely could also lead to the described errors.According to the quality standard and dhr files, a material-, manufacturing- or design-related failure can be excluded.Based upon the investigations results a product safety case (psc) has been initiated.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• Common Device Name: 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: 11886899
• Report Number: 9610612-2021-00406
• Device Sequence Number: 13806207
• Product Code: FZP
• UDI-Device Identifier: 04038653341856
• UDI-Public: 4038653341856
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: 02/16/2026
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52661768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PL572T- LIGATURE CLIP 12 MAG.= 144 PCS. - UNKOWN; PL575SU- CHALLENGER TI-P CO2-CARTRIDGE ONLY
• Patient Sex: Unknown