MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON SNGL LAPRO-CLIP 12MM; DISPOSABLE CLIP APPLIER

Model Number 8886848813

Device Problem Sticking (1597)

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

Event Date 12/20/2013

Event Type  malfunction  

Event Description

Procedure: cholecystectomy.According to the reporter: the laproclip got stuck in the magazine.The second clip pushed above the first one.New clips were used.

Manufacturer Narrative

(b)(4).

• Brand Name: SNGL LAPRO-CLIP 12MM
• Type of Device: DISPOSABLE CLIP APPLIER
• 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 ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4118585
• MDR Text Key: 4943184
• Report Number: 1219930-2014-00875
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1