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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. MAJOR PACK SKIN STAPLER (3M PRECISE PGX 35W) STAPLER, SURGICAL Back to Search Results
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).

 
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Brand NameMAJOR PACK SKIN STAPLER (3M PRECISE PGX 35W)
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
northfield IL 60093
MDR Report Key8901429
MDR Text Key154924491
Report NumberMW5089082
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/13/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device MODEL NumberDYNJ49354
Device Catalogue NumberDYNJ49354
Device LOT Number19EBG608
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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