MAUDE Adverse Event Report: COOPERSURGICAL, INC. SEECLEAR XCL; TUBE, SMOKE REMOVAL, ENDOSCOPIC

Catalog Number SC082500

Device Problem Improper Device Output (2953)

Patient Problem No Information (3190)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

Seeclear smoke evacuator would not evacuate smoke properly during the procedure.

• Brand Name: SEECLEAR XCL
• Type of Device: TUBE, SMOKE REMOVAL, ENDOSCOPIC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 3605284
• MDR Text Key: 4176719
• Report Number: 3605284
• Device Sequence Number: 1
• Product Code: FCZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2014

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 Operator: Unknown
• Device Catalogue Number: SC082500
• Device Lot Number: 147343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER
• Patient Age: 52 YR
• Patient Weight: 66