MAUDE Adverse Event Report: 3M HEALTH CARE PRECISE SKIN STAPLER; DISPOSABLE SKIN STAPLER

Model Number PGX-35W

Device Problems Out-Of-Box Failure (2311); Failure to Fire (2610); Mechanical Jam (2983)

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

Event Date 06/27/2016

Event Type  malfunction  

Event Description

The 3m precise disposable skin stapler would not fire a single staple.It was jammed right out of the package.Diagnosis or reason for use: breast tissue expander exchange.

• Brand Name: PRECISE SKIN STAPLER
• Type of Device: DISPOSABLE SKIN STAPLER
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144
• MDR Report Key: 5761364
• MDR Text Key: 48627630
• Report Number: MW5063172
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: PGX-35W
• Device Catalogue Number: PGX-35W
• Device Lot Number: 2020-11JB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR