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

Model Number PGX-35W

Device Problems Sticking (1597); Mechanical Jam (2983)

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

Event Date 06/21/2017

Event Type  malfunction  

Event Description

A 3m precise disposable skin stapler became stuck upon firing, causing it to jam.

• Brand Name: PRECISE DISPOSABLE SKIN STAPLER
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144
• MDR Report Key: 6700772
• MDR Text Key: 79770270
• Report Number: MW5070890
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: PGX-35W
• Device Catalogue Number: PGX-35W
• Device Lot Number: 2022-02JW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR