MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO DISSECT* 5MM INSTRUMENT; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 176645

Device Problem Failure to Align (2522)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.

Event Description

According to the reporter, the jaws of the laparoscopic instrument were not tangent with each other properly when they are in closed position.

Manufacturer Narrative

(b)(4).

• Type of Device: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• 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: 6303522
• MDR Text Key: 66609457
• Report Number: 2647580-2017-00125
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K904578
• 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: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P6E0109X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1