MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LIGATION / VESSEL CLIPS

Model Number	PL569T
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a ligating clips m/l 12/box (part # pl569t) was used during a procedure performed on (b)(6) 2022.According to the complainant, the first two (2) to three (3) clips worked fine, but then the magazine was pushed away from the clip bar (part # pl538r) at the next activation.This happened inside the patient's abdomen.The complaint device was returned to the manufacturer for evaluation.The patient was not injured.However, an additional medical intervention was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: pl538r - shaft compl.D:10mm l:260mm - lot unknown.Pl510r - handle f/pl506r & pl508r - lot unknown.
Additional Manufacturer Narrative
H6 codes - updated investigation: the investigation was carried out visually and microscopically.Here we found broken off noses, broken off latches and 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 are no similar complaints against the same lot number(2) with this error pattern.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 acceptable.Explanation and rationale: 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.If the cartridge is engaged not completely, has not been mounted correctly or was damaged during inserting, 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.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.According to the investigation results, a product safety case (psc) was initiated.Any action regarding capa will be addressed with this case.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• 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: 13517269
• Report Number: 9610612-2022-00024
• Device Sequence Number: 4158606
• Product Code: FZP
• UDI-Device Identifier: 04038653341375
• UDI-Public: 4038653341375
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K962493
• 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): 04/28/2022

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: 09/16/2026
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52715594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PL510R - LOT UNKNOWN; PL538R - LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown