MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; DBD-GENERAL LAPAROSCOPY - SMH

Model Number DYNJ907730

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, gauze "fibers falling off into patient cavity during surgery".No additional information is available at this time.A sample is not available to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Fraying in surgical cavity.

• Brand Name: Medline Industries, Inc.
• Type of Device: DBD-GENERAL LAPAROSCOPY - SMH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17034289
• MDR Text Key: 316278910
• Report Number: 1423395-2023-00026
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10193489868432
• UDI-Public: 10193489868432
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJ907730
• Device Catalogue Number: DYNJ907730
• Device Lot Number: 21DBQ802
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other