MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS GEM MICROVASCULAR ANASTOMOTIC INSTRUMENT; ANASTOMOTIC INSTURMENT

Model Number GEM2740

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913); Naturally Worn (2988)

Patient Problem Tissue Damage (2104)

Event Date 08/19/2013

Event Type  Injury  

Event Description

On (b)(4) 2014 synovis was notified of complaint uf/importer report # (b)(4) by the fda.A surgeon was performing a venous anastomosis with a gem2751 1.5mm microvascular anastomotic coupler when the knob of the gem microvascular anastomotic instrument used to approximate the coupler rings became stuck and would not advance.When in the course of removing the coupler from the pt, the vessel tore.At this point, the surgeon resected the vessel and completed the anastomosis with a gem2752 2.0mm coupler and another anastomotic instrument which was available to him at (b)(6).The surgery was completed without any further complications and the pd did not experience any injury or adverse outcome.

Manufacturer Narrative

The anastomotic instrument used in this case, serial # (b)(4), was purchased by (b)(6) on (b)(6) 2009.Synovis contacted by (b)(6) on (b)(6) 2013 to have the anastomotic instrument repaired.(b)(6) did not at that time allege any complaint or pt involvement, only to have the instrument repaired.The instrument was returned to (b)(6) as non-repairable on (b)(4) 2013.Synovis has not had access to this instrument for laboratory analysis since becoming aware of the reportable event on (b)(4) 2014.(b)(6) purchased four (4) new anastomatic instruments serial # (b)(4), on (b)(4) 2013.An anastomotic instrument is a reusable (surgical-grade stainless steel, titanium and hard-coat anodized aluminum) surgical tool.According to the device history record for serial # (b)(4), the device met specification prior to market release.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC INSTRUMENT
• Type of Device: ANASTOMOTIC INSTURMENT
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave.; st. paul MN 55114
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; st. paul MN 55114 102
• Manufacturer Contact: scott johnson ; 2575 university ave. w; st. paul, MN 55114-1024 ; 6517967334
• MDR Report Key: 3677246
• MDR Text Key: 4237157
• Report Number: 2183620-2014-00001
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GEM2740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention