COUPLER 512100400060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for COUPLER 512100400060 manufactured by Synovis Surgical Innovations.

Event Text Entries

[144990752] The actual sample was received and the evaluation is complete. The returned unit was labeled for single use. A visual inspection was performed and noted the pin was pointing outward from the rings. The reported condition 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

[144990753] This report summarizes 1 malfunction events. It was reported a coupler had a bent pin. This event occurred prior to use. The device was not used or implanted. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-02319
• MDR Report Key: 8555916
• Date Received: 2019-04-26
• Date of Report: 2019-04-26
• Date Mfgr Received: 2019-03-31
• Date Added to Maude: 2019-04-26
• 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: 2019-04-26
• Model Number: NA
• Catalog Number: 512100400060
• Lot Number: SP19A09-1346282
• 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		2019-04-26