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

Model Number	PL572T
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
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 ligature clip 12 mag.= 144 pcs (part # pl572t) was used during an unknown procedure performed on (b)(6) 2021.According to the complaint description, during surgery, the tip of the clip magazine broke.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.A surgical delay was reported although requested, additional information has not been made available.The malfunction is filed under (b)(4) reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the products arrived in a decontaminated condition with a deformed slider sheet, broken off nose and a clip jam.The broken off part is missing.We made a visual inspection of the products.Here we detected a clip jam, bent latches of the slider sheet, broken off nose and deformations of the slider sheets.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 1 similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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 product safety case (psc (b)(4)) was initiated.Any action regarding capa will be addressed with this case.

• 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
• MDR Report Key: 12384003
• Report Number: 9610612-2021-00585
• Device Sequence Number: 4724639
• 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: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 12/08/2025
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52650978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1