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

Catalog Number	511100200060
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Initial reporter phone no.- (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the pin of a 2.0 mm coupler appeared bent and subsequently "fell out".The issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction h6: medical device problem codes: added a0501 (omitted on initial).The device was received for evaluation.A visual inspection was done which observed that one coupler ring was no longer in the jaw assembly and was free floating in the tray along with the jaw assembly and white protective holder.The investigation performed on the 2.0mm jaw assembly showed signs of use (dried blood) on the jaw assembly.Visual inspection of the 2.0mm coupler ring not in the jaw assembly showed signs of manipulation with a surgical instrument and the coupler ring had five (5) visible coupler pins which is consistent with the reported condition that one ¿pin fell out¿ of the ring.The coupler ring had visible manipulation marks at the location where the sixth coupler pin should have been.Functional testing was not performed.The reported condition of missing pin was verified, however, the reported condition of bent pin could not be verified as the pin was not present.The cause of the condition could not be determined.However, a potential cause could be that manipulation of the coupler pin or ring to improve the pins alleged reported ¿bent¿ position caused the pin to detach from the ring.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.

• Brand Name: COUPLER
• Common Device Name: 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 ; 2242702068
• MDR Report Key: 12522954
• Report Number: 1416980-2021-05881
• Device Sequence Number: 11782146
• Product Code: MVR
• UDI-Device Identifier: 10844735002642
• UDI-Public: 10844735002642
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 511100200060
• Device Lot Number: SP20F16-1458546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown