MAUDE Adverse Event Report: AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM; ANASTOMOSIS DEVICES

Model Number	FC700SU
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
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 fc700su - pas-port proximal anastomosis system.According to the complaint description, the intima-hooks do not fully engage.Pasport has to be uncoupled and the vein has to be removed and put into a second pasport again.Happened during surgery.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: the device has been analysed visually.The pas-port device itself is unused.The tip is still intact and the safety switch is in its starting position.The cartridge has obviously been used.The implant on the tip of the cartrdige is deformed.Furthermore, one of the two provided poke-through tools has been used.This tool must be used to fixate the svg on the implant.If this procedure is fulfilled as intended, 9 equally distributed tiny holes should batch history review: the device history records (dhr) were reviewed for the reported lot number; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures: based upon the investigation results, there is no indication for a product or manufacturing failure.The investigation into the cause of the reported problem was able to confirm the failure mode.A visual examination revealed the presence of a particle.It is assumed that the poke-through procedure in the course of the conduit loading, was not been carried out correctly, which likely resulted in the observed particle.Therefore, the root cause was determined as being usage related.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Common Device Name: ANASTOMOSIS DEVICES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11495996
• Report Number: 9610612-2021-00223
• Device Sequence Number: 16858051
• Product Code: FZP
• UDI-Device Identifier: 04046955241026
• UDI-Public: 4046955241026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202124
• 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): 07/28/2021

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: 08/08/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52646001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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