MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD APPOSE ULC; STAPLE, REMOVABLE (SKIN)

Model Number 8886803712

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, they used it with one staple and a piece broke off and the device would not staple anymore.There was no patient injury.

• Brand Name: APPOSE ULC
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7658848
• MDR Text Key: 113074885
• Report Number: 9612501-2018-01235
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 10884521104372
• UDI-Public: 10884521104372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 8886803712
• Device Catalogue Number: 8886803712
• Device Lot Number: J7K2541LX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2018
• Date Device Manufactured: 10/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1