MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS

Catalog Number	DYNJP3102A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the velcro from the drape "became detached and adhered to the patient's bowel" on (b)(6) 2025 and extended the length of the procedure in order to "remove safely".The customer reported the procedure was able to be completed and there was no report of patient injury.No additional details are available related to the customer reported issue.The customer did not report any 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, the velcro from the drape "became detached and adhered to the patient's bowel" on (b)(6) 2025 and extended the length of the procedure in order to "remove safely".

• Common Device Name: DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS
• 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: 23097425
• Report Number: 1417592-2025-00493
• Device Sequence Number: 8731124
• Product Code: PUI
• UDI-Device Identifier: 10080196778362
• UDI-Public: 10080196778362
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: DYNJP3102A
• Device Lot Number: 39925020013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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 Sex: Unknown