MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ANGIOLOCK,MED/LRG,POLY,6/CT,14CT/BX

Catalog Number	MDS6PML1
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, on (b)(6) 2026, "during a robot cholecystectomy with cholangiogram procedure, medium/large clips wouldn't lock/stay closed when surgeon was trying to clip the artery.
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, "during a robot cholecystectomy with cholangiogram procedure, medium/large clips wouldn't lock/stay closed when surgeon was trying to clip the artery.The team was using a davinci medium/large clip applier.No harm to the patient occurred.Staff in the room opened a different pack of clips to use for the procedure.They were from a different manufacturer.No issues were noted at the patient's follow up appointment.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
• Common Device Name: ANGIOLOCK,MED/LRG,POLY,6/CT,14CT/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24719886
• Report Number: 1417592-2025-00761
• Device Sequence Number: 6087763
• Product Code: DSS
• UDI-Device Identifier: 10193489144772
• UDI-Public: 10193489144772
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220006
• 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): 03/27/2026

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 Expiration Date: 07/26/2024
• Device Catalogue Number: MDS6PML1
• Device Lot Number: 300564486
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/30/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Race: White