MAUDE Adverse Event Report: COVIDIEN LP, FORMERLY US SURGICAL ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP; DISPOSABLE CLIP APPLIER

Catalog Number 176630

Device Problems Break (1069); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Date 06/14/2012

Event Type  malfunction  

Event Description

Procedure: lap chole.According to the reporter: the device was broken out of the box.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP
• Type of Device: DISPOSABLE CLIP APPLIER
• Manufacturer (Section D): COVIDIEN LP, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer Contact: sharon murphy, qa ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4041016
• MDR Text Key: 18792907
• Report Number: 1219930-2014-00607
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2017
• Device Catalogue Number: 176630
• Device Lot Number: N2C0294X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1