MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; GENERAL LAPAROSCOPY 668608-V

Catalog Number DYNJ58503A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the control syringe broke during use.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the control syringe broke during use.

• Type of Device: GENERAL LAPAROSCOPY 668608-V
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18860046
• MDR Text Key: 337583896
• Report Number: 1423395-2024-00125
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10193489818833
• UDI-Public: 10193489818833
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2024

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 Catalogue Number: DYNJ58503A
• Device Lot Number: 21IMD971
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1