MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SM OR-DR. YEH PACK-LF

Catalog Number	DYNJ69705C
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, small white fragments of the clip holder material have been coming off with the clip when loaded into the clip appliers several times.The customer reported that on (b)(6) 2025, the surgeon had to remove small white pieces of plastic with forceps from an open thyroidectomy wound after clip application.No identifiable defects were noted with the clips prior to use.The clip appliers used were vesocclude applier 8" sm/red teleflex inc (b)(4) and vesocclude applier 8" medium teleflex inc (b)(4).The customer stated that all fragments were recovered from the wound and that the surgery was completed.The customer reported that the patient was discharged the following day and that there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.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 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 customer, small white fragments of the clip holder material have been coming off with the clip when loaded into the clip appliers several times.The customer reported that on (b)(6) 2025, the surgeon had to remove small white pieces of plastic with forceps from an open thyroidectomy wound after clip application.

• Common Device Name: SM OR-DR. YEH PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22826512
• Report Number: 1423395-2025-00091
• Device Sequence Number: 4463549
• Product Code: LRO
• UDI-Device Identifier: 10198459164460
• UDI-Public: 10198459164460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/18/2025

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: DYNJ69705C
• Device Lot Number: 25DMA339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 40 KG