MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ROBOTIC LAPAROSCOPY PACK

Catalog Number	DYNJ905742I
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that teh light handle in the pack is cracked upon delivery.
Additional Manufacturer Narrative
It was reported that the cracked light handle cover.Medline's investigation received one photo and a physical sample for one light handle cover; the rest of the pack was not available, finished good production records were reviewed, and finished good pack build was reviewed.Medline observed the light handle cover out of its original packaging with a crack on the handle, confirming the reported issue.Further investigation reveals that the root cause is attributed to a vendor product issue related to the component manufacturing process; this complaint has been provided to the vendor for further evaluation and supplier quality 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.

• Brand Name: MEDLINE
• Common Device Name: DBD-ROBOTIC LAPAROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883916
• Report Number: 1417592-2026-49901
• Device Sequence Number: 21509923
• Product Code: OHD
• UDI-Device Identifier: 40195327560257
• UDI-Public: 40195327560257
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 09/23/2026

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: DYNJ905742I
• Device Lot Number: 24GMA133
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/08/2024
• 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: 10/30/2024
• Initial Report FDA Received Date: 09/24/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown