MAUDE Adverse Event Report: COVIDIEN APPOSE ULC 35 WIDE SKIN STAPLER; DISPOSABLE SURGICAL STAPLING DEVICE

Catalog Number 8886803712

Device Problem Break (1069)

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

Event Date 03/24/2014

Event Type  Injury  

Event Description

According to the reporter: the gray slider on the back of the stapler broke into pieces.Doctor was aware and an x-ray was ordered.X-ray showed no pieces in the pt.The broken pieces were found on the floor.All pieces noted to be there.There was no pt harm, but pt received additional x-ray exposure.

Manufacturer Narrative

(b)(4).

• Brand Name: APPOSE ULC 35 WIDE SKIN STAPLER
• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): DAVIS AND GECK CARIBE, LTD.; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy, qa ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3818072
• MDR Text Key: 4448436
• Report Number: 9612501-2014-00143
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8886803712
• Device Lot Number: 10/31/2018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other