MAUDE Adverse Event Report: SYNOVIS MICRO COMPANIES ALLIANCE, INC GEM FLOW COUPLER; DEVICE,ANASTOMOTIC,MICROVASCULAR

Catalog Number	515191300010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a flowcoupler probe cable was not connected and the ring disconnected during conditioning.The event occurred during an unknown process step during an unspecified surgery.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation.During review of the photo provided of the 3.0mm flow coupler product, no damage to any portion of the flow coupler product (jaw/probe assembly) was noted.Additionally, there were no signs of use present which is consistent with the complainant¿s statement that the alleged event occurred prior to use.The user would likely detect this issue during product set-up prior to patient use.The user would also have the option to use a new device.After consideration for potential harms and worst-case scenarios, there would be no adverse health consequence reasonably expected to result from this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GEM FLOW COUPLER
• Common Device Name: DEVICE,ANASTOMOTIC,MICROVASCULAR
• Manufacturer (Section D): SYNOVIS MICRO COMPANIES ALLIANCE, INC; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19607348
• Report Number: 1416980-2024-03156
• Device Sequence Number: 6520362
• Product Code: MVR
• UDI-Device Identifier: 00844735006018
• UDI-Public: (01)00844735006018(10)SP22J041746549(17)271003
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K132727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 515191300010
• Device Lot Number: SP24J04-1746549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown