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

Model Number GEM2751

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Synovis has elected to submit mdrs related to coupler malfunctions regardless if the event was considered likely or unlikely to cause or contribute to death or serious injury.The device history record for this lot number was reviewed.100% visual inspection for broken or missing parts and pin alignment is performed on each assembly during the manufacturing process.The ring retention force is within specification.According to the device history record, the device met specification prior to market release.Two coupler rings and one wing jaw assembly were returned for evaluation.Both coupler rings appeared to be in good condition.Three pins of one coupler ring were bent.Both rings had visual evidence of blood and/or tissue.The wing jaw assembly also had residual dry blood.No functional testing was performed.The coupler rings were returned loose, not in the wing jaw assembly.The customer report states that the ring slid out during setup, but both rings have blood on the surface, which would indicate that the ring was in contact with the patient or surgical field.The event could not be confirmed.There is no immediate evidence to support why the ring did not stay in the wing jaw during use.No additional information is available at this time.

Event Description

It was reported that during setup, a 1.5mm gem2751 coupler ring slid out of the wing jaw assembly.No patient adverse event was reported.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Type of Device: ANASTOMOTIC COUPLER
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5410706
• MDR Text Key: 37740081
• Report Number: 1416980-2016-02619
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Model Number: GEM2751
• Device Catalogue Number: 511100150010
• Device Lot Number: SP15C20-1039412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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