COUPLER 511100250060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for COUPLER 511100250060 manufactured by Synovis Surgical Innovations.

Event Text Entries

[143679653] The actual device was received for evaluation. The returned unit was labeled for single use. A visual inspection was performed and it was found the rings were visibly misaligned. The reported problem was verified. The cause of the condition could not be determined. A device history review revealed no issues that could have caused or contributed to the reported issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[143679654] This report summarizes 1 malfunction events. It was reported that a pin on the coupler ring was defective or misplaced, and the rings were unable to fully attach. This event occurred during preparation of the device. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-02219
• MDR Report Key: 8547288
• Date Received: 2019-04-24
• Date of Report: 2019-04-24
• Date Mfgr Received: 2019-03-31
• Date Added to Maude: 2019-04-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal: 60073
• Manufacturer Phone: 2242702068
• Manufacturer G1: SYNOVIS SURGICAL INNOVATIONS
• Manufacturer Street: 2575 UNIVERSITY AVE. W
• Manufacturer City: SAINT PAUL MN 55114
• Manufacturer Country: US
• Manufacturer Postal Code: 55114
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: COUPLER
• Generic Name: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Product Code: MVR
• Date Received: 2019-04-24
• Model Number: NA
• Catalog Number: 511100250060
• Lot Number: SP18D19-1301460
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SYNOVIS SURGICAL INNOVATIONS
• Manufacturer Address: SAINT PAUL MN

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-24