MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-DAVINCI LITHOTOMY PACK

Catalog Number	DYNJ48057N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported finding irrigator leaking.A sample was received; medline received one used suction irrigator for sample review, no additional pack contents were returned, there were no cracks or kinks seen with the tubing, the remaining liquid within the tubing was manipulated and it did not leak, both buttons were tested and they did not stick, and the batteries were not returned so functionality or power could not be tested.As no defects were noted with the received sample, medline could not confirm the reported defect.Finished good production records and the finished good pack build were reviewed, no issues were noted that could contribute to the reported issue, the complaint was provided to the vendor for further evaluation, and the division will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
Event or Problem Description
It was reported that "the laparoscopic suction is leaking everywhere upon opening the pack." it was also reported, "this has affected multiple packs.".

• Brand Name: MEDLINE
• Common Device Name: DBD-DAVINCI LITHOTOMY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50222645
• Report Number: 1417592-2026-15917
• Device Sequence Number: 5545615
• Product Code: OHD
• UDI-Device Identifier: 10198459255717
• UDI-Public: 10198459255717
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: DYNJ48057N
• Device Lot Number: 25IME150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female