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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS GEM MICROVASCULAR ANASTOMOTIC COUPLER; DEVICE,ANASTOMOTIC,MICROVASCULAR

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SYNOVIS SURGICAL INNOVATIONS GEM MICROVASCULAR ANASTOMOTIC COUPLER; DEVICE,ANASTOMOTIC,MICROVASCULAR Back to Search Results
Model Number GEM2753
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).A supplemental report will be submitted upon completion of the returned product evaluation.
 
Event Description
It was reported that a gem 2.0mm coupler had a bent pin.The coupler ring was adequately removed from the vein and the anastomosis was completed with another coupler.This occurred during an unspecified surgery.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Aware date 12/21/2017, based on completed evaluation (b)(4) a device history record review was completed.No irregularities were found when reviewing supplier records.Ring separation testing was competed at the supplier with passing results.100% functional alignment testing was performed on each device during the manufacturing process.In addition, 100% visual inspection for broken or missing parts was performed.Ring retention testing was completed at incoming inspection with passing results.The released product met specification.Two 2.5mm gem coupler wing jaws were returned for evaluation.No coupler rings were returned.One device has a broken hinge.The other is normal.No functional testing was performed as the device has a broken hinge.The allegation of the coupler not closing properly cannot be refuted.Evaluation of the returned device confirms that the device is broken.The broken hinge can allow the wing jaw to rotate past the hinge stop tab.A broken coupler wing jaw renders the device nonfunctional.It is unknown how the device was handled prior to the event.The surgeon detected the device defect and completed the anastomosis with a new coupler.
 
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Brand Name
GEM MICROVASCULAR ANASTOMOTIC COUPLER
Type of Device
DEVICE,ANASTOMOTIC,MICROVASCULAR
Manufacturer (Section D)
SYNOVIS SURGICAL INNOVATIONS
saint paul MN
Manufacturer (Section G)
BAXTER HEALTHCARE - SAINT PAUL
2575 university ave w
saint paul MN 55114
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7049746
MDR Text Key93070074
Report Number1416980-2017-09246
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K861985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/04/2018
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
Device Operator Health Professional
Device Expiration Date05/04/2020
Device Model NumberGEM2753
Device Catalogue Number511100250010
Device Lot NumberSP17F261236925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2017
Initial Date FDA Received11/21/2017
Supplement Dates Manufacturer Received12/21/2017
Supplement Dates FDA Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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