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

Model Number	FC700SU
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer 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 pas-port proximal anastomosis system (part # fc700su) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the surgery, the staples were deployed outside of the aorta.After the anastomosis, the staples was deployed outside the aorta and only left a hole in the aorta.A side clamp was used on the aorta and the hole was closed by hand sewing.It is not currently known how the case was completed.The nurse threw away the pps body with the saphenous vein graft (svg) inside.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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 5 similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a product safety case (b)(4) was initiated.Any action regarding capa will be addressed with this case.A product recall (b)(4) was initiated.Product not sold nor marketed any longer.

• 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: 12004473
• Report Number: 9610612-2021-00438
• Device Sequence Number: 14342514
• Product Code: FZP
• UDI-Device Identifier: 04046955241026
• UDI-Public: 4046955241026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 05/24/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52632015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 10/28/2021
• 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