MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-PRENTICE GYN LAPAROSCOPY KIT

Catalog Number	DYNJ908791C
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was a quality issue with this kit only containing 9 raytecs.No sample or photo received for our investigation; finished good production records were reviewed, and no non-conformances were noted that could have contributed to the reported issue, and a thorough review of the pack build was conducted with no issues found with the build that would likely contribute to the reported issue.The defect was unconfirmed; the cause code description was "sample required to determine cause." medline receives this item pre-counted and banded from the component supplier and no further processing is performed during pack assembly, so the investigation noted the root cause is likely related to an error in the component manufacturing process; supplier quality will monitor this issue for trending purposes, a risk assessment found the incident acceptable, and there has been no change to the reportability decision.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 "9 raytecs in custom gyn laparoscopy pack.".

• Brand Name: MEDLINE
• Common Device Name: DBD-PRENTICE GYN LAPAROSCOPY KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50298978
• Report Number: 1417592-2026-18287
• Device Sequence Number: 21507389
• Product Code: OHD
• UDI-Device Identifier: 10198459103445
• UDI-Public: 10198459103445
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: DYNJ908791C
• Was Device Available for Evaluation?: Yes
• 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: 01/14/2023
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown