MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. TUFFIER ; RIB SPREADER

Model Number 54-2242

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

Symmetry surgical receive the device back from the customer on 09/09/2015, the device was visually inspected and determined the device had been used beyond its intended life.The device was purchased prior to 2011 from another company.Customer did not want a replacement for the broken device.

Event Description

The surgeon made an incision along the posterior axillary line, approx the fifth interspace carried down through various layers with electrocautery.The lung was deflated and the chest was entered.The scope was placed.Adhesion was broken up with thorascope.The scope was then removed.The incision was opened to a thoracotomy.Partial pleurectomy and total decortication was performed.Bronchopleural (bp) fistula was wedged with endo-dia stapling device.Tuffier retractor was in the left chest.To detract incision and remove tuffier, the knob needed to turn and retractor broke off.The surgeon had to extend the incision to remove the irrigated with copious amounts of antibiotic solution.Two chest tubes were placed.The pt tolerated the procedure well and wen to cv intensive c.

• Brand Name: TUFFIER
• Type of Device: RIB SPREADER
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013 3272
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 5127970
• MDR Text Key: 27505021
• Report Number: 3007208013-2015-00024
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00887482079379
• UDI-Public: 00887482079379
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 54-2242
• Device Catalogue Number: 54-2242
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2015
• Distributor Facility Aware Date: 08/17/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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 Age: 58 YR