MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; HANDHELD PRODUCTS & LIGATION

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	02/04/2021
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 pl572t-ligature clip 12 mag.= 144 pcs.According to the complaint description, the clips detached from the clamp in the patient's abdomen.When the barrette was taken, she has broken.Available for analysis.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results visual investigation: the investigation was carried out visually and microscopically with the digital microscope (b)(6) keyence (eq.-nr.(b)(4)) and the digital-camera panasonic dmc tz8".We made a visual inspection of the product.Here we detected some scratches and fractures on the cartridge.The product is broken into 2 pieces and the slider sheet is bent.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.Conclusion and measures / preventive measures: 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.Due to the many damages on the cartridge, it is not possible to determine an exact conclusion.There is the possibility for an application error, for example due to an assembly error when mounting the cartridge.Based upon the investigations results a capa is not necessary.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• Common Device Name: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11426577
• Report Number: 9610612-2021-00123
• Device Sequence Number: 2855155
• 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): 08/04/2021

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: 12/08/2025
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52650978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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