MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number 5111-00300-060

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received for evaluation.During visual investigation, it was noted that the returned product showed signs of use (dried blood) which is consistent with the reporter¿s statement that the alleged event occurred during use.The reported condition was verified.However, the cause of the condition could not be determined because the returned coupler rings had been successfully approximated (brought together aligned and tightly closed) and were no longer attached in the ¿u port) of the coupler jaw assembly.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.

Event Description

It was reported that the ring of a 3.0mm coupler was not fully fixed on the u port and was unable to be pushed out of the anastomotic instrument.It was further reported that this issue was identified during patient use.The surgeon used another coupler to complete the case.There was no report of patient injury or medical intervention associated with this event.It was further reported, the ¿patient was doing well¿.No additional information is available.

• Brand Name: COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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: 11089228
• MDR Text Key: 224755629
• Report Number: 1416980-2020-08151
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5111-00300-060
• Device Lot Number: SP20G071462251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1