MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE MAJOR PACK - STAPLER PRECISE PGX 35W; STAPLER, SURGICAL

Model Number DYNJ49354

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Mechanical Jam (2983)

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

Event Date 12/20/2019

Event Type  malfunction  

Event Description

Precise pgx 35w stapler in medline major pack jammed after 4-5 firings.An attempt to dislodge the jaws was made by squeezing the handle in the normal fashion, however, this resulted in the stapler breaking apart in many pieces spread throughout the operating room.Fda safety report id# (b)(4).

• Brand Name: MEDLINE MAJOR PACK - STAPLER PRECISE PGX 35W
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 9526005
• MDR Text Key: 173192665
• Report Number: MW5091916
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: DYNJ49354
• Device Catalogue Number: DYNJ49354
• Device Lot Number: 19HBR672
• 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: 81 YR