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

[143726102] This is a summary report for one unit lot # sp18h22-1321191 and six units of unknown lot. Of the seven events, one actual device was returned for evaluation. The returned unit was labeled for single use. A visual inspection was performed and it was noted that one of the two rings returned showed signs of being manipulated with an instrument (ring material displacement). The second ring had no visual defects (bent pins, scuffs, displaced material), only dried material consistent with contact to the human body. With both rings not seated in the jaw assembly it could be implied that the ring dislodged from the jaw assembly. The reported condition was verified. The cause of the reported condition could not be determined. A device history review was conducted and no irregularities were found when reviewing supplier records. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[143726104] This report summarizes 7 malfunction events. It was reported that seven coupler had rings dislodge. Six of the devices had a ring fall out of the wing jaw assembly, and one of the devices had popped in half. Of the seven events, six did not involve a patient, and one involved a patient with no patient consequences. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-02218
• MDR Report Key: 8547287
• Date Received: 2019-04-24
• Date of Report: 2019-07-26
• Date Mfgr Received: 2019-06-30
• 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 55144
• Manufacturer Country: US
• Manufacturer Postal Code: 55144
• 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: SEE H10
• Device Availability: *
• Device Age: DA
• 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