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

Model Number 8886803512

Device Problems Entrapment of Device (1212); Failure to Form Staple (2579); Failure to Fire (2610); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, when the device was being used on the skin during the removal of an implanted venous access device, the staple deployed completely from the stapler and not form properly.It was also stated that the stapler would stick and jam, and the staple either would not come out or would not be not be implanted on the skin properly and would need to be removed and try again.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: 10383552
• MDR Text Key: 202187268
• Report Number: 9612501-2020-01134
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 10884521104365
• UDI-Public: 10884521104365
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K900486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8886803512
• Device Catalogue Number: 8886803512
• Device Lot Number: J9G0636LY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/10/2020
• Date Device Manufactured: 07/09/2019
• 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