MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ROTICULATOR ENDO GRASP* 5MM W/SPIN LOCK; SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS

Model Number 174233

Device Problems Collapse (1099); Material Protrusion/Extrusion (2979)

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

Event Date 05/06/2015

Event Type  malfunction  

Event Description

According to the reporter: two endo grasps were used in this case.In regards to the first device: the black sheath on the tip collapses on itself when the tip comes out.In regards to the second device: piece of plastic protruding from side of tip.Reporter had no further information.

Manufacturer Narrative

(b)(4).First device reported in (b)(4) and second device reported in (b)(4).

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: 4776889
• MDR Text Key: 5799439
• Report Number: 2647580-2015-00353
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914753
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 174233
• Device Catalogue Number: 174233
• Device Lot Number: P2L0246X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1