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	01/19/2021
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 to aesculap ag that a ligature clip (part # pl572t) was used during a robotic prostatectomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the clips were found to be defective.Reportedly, several clip-on cartridges were used, but failed to function properly.The procedure was able to be continued and completed after changing to a different batch of clips.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).Involved components: pl530r - clip applier/remover angle d:12.5/350mm - lot: unknown.Pl530r - clip applier/remover angle d:12.5/350mm - lot: unknown.
Additional Manufacturer Narrative
Involved components: pl530r - clip applier/remover angle d:12.5/350mm - lot: unknown.Pl530r - clip applier/remover angle d:12.5/350mm - lot: unknown.Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We made a visual inspection of the products and we detected that the date for maintenance of pl510r was not observed.The parts of pl522r have been mixed up, the maintenance date of only one part of the product was not observed.Furthermore the products were send to the quality assurance of the production department for further analysis.Based on the investigation results of the quality assurance of the production department: no error can be detected on the production side.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 root cause specific risk cannot be identified due to the raoot cause,which we can not finally concluded.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.
Event or Problem Description
Involved components: pl530r - clip applier/remover angle d:12.5/350mm - lot: unknown.Pl530r - clip applier/remover angle d:12.5/350mm - lot: unknown.

• 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: 11308926
• Report Number: 9610612-2021-00084
• Device Sequence Number: 1165282
• Product Code: FZP
• UDI-Device Identifier: 04038653341856
• UDI-Public: 4038653341856
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/27/2021

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: 11/05/2025
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52642790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: PL530R; PL530R
• Outcome Attributed to Adverse Event: Required Intervention