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

Model Number	FC700SU
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
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, during rotating the knob of the delivery system to fired the staple to aorta, some kind of a chip such as the material of pps came off the device.As the chip might come off the knob of the device and fell on the distal end of the housing of delivery device, the chip was easy to see and retrieved from the point.The anastomosis itself with use of the pps was completed without any problem.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 is filed under (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the particles have been analysed visually.The particles were provided inside of liquid.A clear assignment of the particles is not possible, especially without the pasport device itself.It is possible that these are plastic particles from inside the device, but how and why the occurred cannot be finally determined.Based on the provided information and after the investigation, a clear conclusion cannot be drawn.There is no indication for a manufacturing or material failure according to the dhr files.The separated particle cannot be assigned, especially without the pasport device itself.On the basis of the statistical analysis and market surveillance, this is an individual case.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: 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.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Common Device Name: ANASTOMOSIS DEVICES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11769163
• Report Number: 9610612-2021-00354
• Device Sequence Number: 19941957
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 04/24/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52627199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown