MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-LAP CHOLE PACK-LF

Catalog Number	DYNJ0459846V
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 a sponge "came apart" while removing it from the patient with a "trocar".The customer reported a "robotic camera" was utilized to explore the abdomen and an "x-ray" was performed, but there were no fragments of the sponge identified inside the patient.The customer did not report any serious injury related to the reported incident.No additional information is available.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, on (b)(6) 2024 a sponge "came apart" while removing it from the patient with a "trocar".

• Common Device Name: DBD-LAP CHOLE PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21048191
• Report Number: 1423395-2024-00520
• Device Sequence Number: 8409271
• Product Code: FDE
• UDI-Device Identifier: 40195327570560
• UDI-Public: 40195327570560
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/31/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: DYNJ0459846V
• Device Lot Number: 24FMJ610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/31/2024
• 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: 82 YR
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic