MAUDE Adverse Event Report: CONMED CORPORATION 87K ARTHROSCOPY; ARTHROSCOPE

Model Number	87100
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
3m pump tubing pressure sensing bulb is not functioning properly.

• Brand Name: 87K ARTHROSCOPY
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 15470118
• Report Number: 15470118
• Device Sequence Number: 4274420
• Product Code: HRX
• UDI-Device Identifier: 20845854041137
• UDI-Public: (01)20845854041137
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/15/2022
• Report Date (Section F): 09/15/2022

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
• Device Model Number: 87100
• Device Catalogue Number: 87100
• Device Lot Number: 202110134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2022
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/15/2022