MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC; GENERAL SURGERY TRAY

Model Number ACF PACK SJO-LF

Device Problems Product Quality Problem (1506); Unintended Movement (3026); Firing Problem (4011)

Patient Problem Insufficient Information (4580)

Event Date 04/15/2021

Event Type  malfunction  

Event Description

The stapler is in the medline pack acf pack.The neuro service feedback is that the covidien skin staplers are inferior.Also when stapling incision it is not a consistent stapler.The staples lift up/fall out and do not secure on skin.

• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes drive; northfield IL 60093
• MDR Report Key: 11723475
• MDR Text Key: 247290095
• Report Number: 11723475
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACF PACK SJO-LF
• Device Catalogue Number: DYNJ66327
• Device Lot Number: 20JKB358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 74