MAUDE Adverse Event Report: SYNERGY HEALTH STRYKER; MONOPOLAR SUCTION / IRRIGATION POLE

Model Number 250-070-443

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2016

Event Type  malfunction  

Manufacturer Narrative

Original complaint stated insulation was found in lumen of device after surgery.Based on the additionally obtained information on 10/25/2016 at 3:16pm from (b)(6), there was no delay of surgery or adverse event occurred.Laparoscopic insulation was found after surgery and not present during surgery.No details were recorded or maintained by rex healthcare.

Event Description

Laparoscopic insulation found inside monopolar suction / irrigation pole.No delay to procedure.Event did not cause harm.

• Brand Name: STRYKER
• Type of Device: MONOPOLAR SUCTION / IRRIGATION POLE
• Manufacturer (Section D): SYNERGY HEALTH; 1416 dogwood way; raleigh NC 27302
• Manufacturer (Section G): SYNERGY HEALTH
• Manufacturer Contact: bradley jensen ; 1416 dogwood way; raleigh, NC 27302 ; 9195638555
• MDR Report Key: 6058924
• MDR Text Key: 58846778
• Report Number: 0001055892-2016-00005
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 250-070-443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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