MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA ROTICULATOR* 60-4.8 SULU; DISPOSABLE SURGICAL STAPLING DEVICE

Model Number 030459

Device Problems Crack (1135); Difficult to Open or Close (2921); Noise, Audible (3273)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 10/07/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Procedure type: lap sigmoid.According to the reporter: the reload was properly loaded on the instrument, however, the doctor was unable to close the jaws.When it was attempted to be closed by force, a loud crack was heard.There was two centimeters of intestinal tissue which was damaged and removed.There was no other injury.Another reload and the same instrument were used to finish successfully.There was no blood loss or extension of surgery time.

Manufacturer Narrative

(b)(4).

• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 2034925267
• MDR Report Key: 4227658
• MDR Text Key: 12865727
• Report Number: 1219930-2014-01008
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K900129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 030459
• Device Catalogue Number: 030459
• Device Lot Number: N3L1302LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: PRODUCT NUMBER: EGIAUSTND
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Weight: 67