MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MAJOR PACK SKIN STAPLER (3M PRECISE PGX 35W); STAPLER, SURGICAL

Model Number DYNJ49354

Device Problems Break (1069); Difficult to Open or Close (2921)

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

Event Date 08/12/2019

Event Type  malfunction  

Event Description

Precise pgx 35w stapler from medline industries major pack was locked open, unable to be closed.The stapler ultimately broke into approx 4-5 pieces as it was attempted to be activated.Fda safety report id# (b)(4).

• Brand Name: MAJOR PACK SKIN STAPLER (3M PRECISE PGX 35W)
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 8901429
• MDR Text Key: 154924491
• Report Number: MW5089082
• Device Sequence Number: 1
• Product Code: GAG
• 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: 08/13/2019

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 Expiration Date: 09/30/2020
• Device Model Number: DYNJ49354
• Device Catalogue Number: DYNJ49354
• Device Lot Number: 19EBG608
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2019
• 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: 54 YR