MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; LAP DONOR NEPHRECTOMY KIT

Model Number DYNJ908787

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/16/2023

Event Type  Injury  

Event Description

According to the facility on (b)(6) 2023 during a procedure the gauze began to fray while inside the patient.

Manufacturer Narrative

According to the facility on (b)(6) 2023 during a procedure the gauze began to fray while inside the patient.Per the facility the gauze had to be removed from the patient "with instrumentation during a robotic procedure".Per the facility the product was inspected prior to use and was being used for "hemostasis".Per the facility an "intraop x-ray was completed and all remnants were collected".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Type of Device: LAP DONOR NEPHRECTOMY KIT
• 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: 17248193
• MDR Text Key: 318344271
• Report Number: 1423395-2023-00032
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10195327183462
• UDI-Public: 10195327183462
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ908787
• Device Catalogue Number: DYNJ908787
• Device Lot Number: 23DDB156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2023
• 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