MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DAVINCI PACK

Catalog Number	DYNJ53752C
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, while intra-op, "a foreign body was found inside the abdomen of the patient.Object is believed to be a piece from the microline scissor tip that comes inside the pack." per the facility, "the piece was immediately removed, intraabdominal inspection was completed.All parts of the foreign object were removed." facility reports no serious injury, medical intervention or follow-up care related to the incident.The procedure was completed.No additional information at this time.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.
Event or Problem Description
According to the facility, while intra-op, "a foreign body was found inside the abdomen of the patient.Object is believed to be a piece from the microline scissor tip that comes inside the pack." per the facility, "the piece was immediately removed, intraabdominal inspection was completed.All parts of the foreign object were removed." facility reports no serious injury, medical intervention or follow-up care related to the incident.

• Common Device Name: DAVINCI PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23543265
• Report Number: 1423395-2025-00190
• Device Sequence Number: 18503885
• Product Code: OHD
• UDI-Device Identifier: 10195327652012
• UDI-Public: 10195327652012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ53752C
• Device Lot Number: 25FBS347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 89 KG