MAUDE Adverse Event Report: CONMED CORPORATION LAPVUE10; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	LAPVUE10
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Defective scope warmer, new one that we started to use would not activate at all before or during the case.Fda safety report id# (b)(4).

• Brand Name: LAPVUE10
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 15498697
• Report Number: MW5112282
• Device Sequence Number: 19284176
• Product Code: GCJ
• UDI-Device Identifier: 20845854061746
• UDI-Public: (01)20845854061746
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: 08/07/2025
• Device Model Number: LAPVUE10
• Device Catalogue Number: LAPVUE10
• Device Lot Number: 25022080810
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown