MAUDE Adverse Event Report: XODUS MEDICAL INC. SEE SHARP; ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY

Catalog Number	30977
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Tampon or trocar cleaning device when placed in trocar the plastic flaked off tampon but the flakes were retrieved from trocar.Fda safety report id # (b)(4).

• Brand Name: SEE SHARP
• Common Device Name: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): XODUS MEDICAL INC.
• MDR Report Key: 12353998
• Report Number: MW5103405
• Device Sequence Number: 4739714
• Product Code: OCT
• UDI-Device Identifier: 00787551037029
• UDI-Public: (01)00787551037029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: 30977
• Device Lot Number: 21JUL08
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1