MAUDE Adverse Event Report: XODUS MEDICAL, INC. SEE SHARP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	30977
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
During laparoscopic case, blue, plastic part of tampon portion of the see sharp (ref 30977) was scraped upon entry into trocar.The plastic scraping actually came off and onto the field.Fda safety report id # (b)(4).

• Brand Name: SEE SHARP
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): XODUS MEDICAL, INC.
• MDR Report Key: 12384908
• Report Number: MW5103570
• Device Sequence Number: 20173655
• Product Code: GCJ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 21JUL26
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1