MAUDE Adverse Event Report: COVIDIEN LP VALLEYLAB STRAIGHT EXTENSION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number E1502

Device Problems Hole In Material (1293); Material Protrusion/Extrusion (2979)

Patient Problem Bowel Burn (1756)

Event Date 05/02/2017

Event Type  malfunction  

Event Description

The surgeon was using the surgical pencil extender with the surgical pencil in the abdomen.After several minutes the resident noticed burns and holes in the bowel.The surgical tech and surgeon inspected the surgical pencil and they both found a hole in the insulation around the it.The hole in the insulation was deep enough that metal was being exposed on the extender resulting in burns and holes in the bowel.

Event Description

The surgeon was using the surgical pencil extender with the surgical pencil in the abdomen.After several minutes the resident noticed burns and holes in the bowel.The surgical tech and surgeon inspected the surgical pencil and they both found a hole in the insulation around the it.The hole in the insulation was deep enough that metal was being exposed on the extender resulting in burns and holes in the bowel.The bovie extender was given to our inventory specialist to send back to the manufacturer for inspection and follow up.The grounding pad was placed on the patients right buttock and the generator settings were 50cut/70coag.

• Brand Name: VALLEYLAB STRAIGHT EXTENSION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6550971
• MDR Text Key: 74602801
• Report Number: 6550971
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: E1502
• Device Catalogue Number: E1502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TRIAD GENERATOR
• Patient Outcome(s): Other
• Patient Age: 58 YR