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

Catalog Number SC082500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

Robotic-assisted total laparoscopic hysterectomy with robotic assisted and bilateral salpingo-oophorectomy, cystoscopy.During the procedure the smoke evacuation tubing had sub-optimal smoke evacuation, delaying the procedure until smoke cleared from the abdominal cavity.Per staff, "it took a long time and the product does not work well".Unsure of exact amount of time.We have had repeated issues with the product according to our staff.There was no harm to the patient.

• 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: 3732816
• MDR Text Key: 4323976
• Report Number: 3732816
• 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: 03/28/2014

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: Physician
• Device Catalogue Number: SC082500
• Device Lot Number: 147344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2014
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 74