MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO MINI-SHEARS* 5MM INSTRUMENT; SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS

Model Number 174301

Device Problems Overheating of Device (1437); Sparking (2595); Material Deformation (2976)

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

Event Date 10/20/2014

Event Type  malfunction  

Event Description

Procedure: lap colon.According to the reporter: two devices from the same lot number were used and sparks cameout of the tip.It was observed as well that the distal end of the devices got too warm until it got deformed.

Manufacturer Narrative

(b)(4).Initial report sent to fda on 11/03/2014.

Manufacturer Narrative

(b)(4).

• Type of Device: SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4220638
• MDR Text Key: 5000440
• Report Number: 2647580-2014-00931
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K903206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 174301
• Device Catalogue Number: 174301
• Device Lot Number: P3J0714X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1