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

Model Number GEM2752 I

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Event Description

Parts were missing from synovis gem microvascular anastomotic coupler device.New package obtained.Sending back first for credit.No harm to patient.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): SYNOVIS MICRO COMPANIES ALLIANCE, INC; 439 industrial ln; birmingham AL 35211
• MDR Report Key: 10573009
• MDR Text Key: 208146194
• Report Number: 10573009
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/16/2020

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
• Device Operator: No Information
• Device Model Number: GEM2752 I
• Device Catalogue Number: 511100200010
• Device Lot Number: SP19E06-1371114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2020
• Date Report to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA