MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE INDUSTRIES, INC.; GYNECOLOGICAL LAPAROSCOPIC KIT

Model Number DYNJ80060

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

The 11 blade in pack was noted to be dull requiring another blade to be placed on field.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD; three lakes drive; northfield IL 60093
• MDR Report Key: 15814275
• MDR Text Key: 303832543
• Report Number: 15814275
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 10195327010430
• UDI-Public: (01)10195327010430
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ80060
• Device Catalogue Number: DYNJ80060
• Device Lot Number: (10)22EBS295
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1