MAUDE Adverse Event Report: SMITH & NEPHEW, INC., ENDOSCOPY DIVISION COBLATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EICA5872-01

Device Problems Decrease in Suction (1146); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Event Description

During the procedure, tonsillectomy & adenoidectomy, the surgeon began to have difficulty with the coblator evac 70 xtra disposable hand piece.There were difficulties with the suction of the hand piece and not functioning the way that it routinely does.The suction canister was checked and determined it was working normally.The hand piece was changed and the new one worked appropriately.No harm to the patient occurred.Malfunction of the coblator evac 70 xtra disposable hand piece used in ear nose and throat (ent) surgery.It was not functioning as usual in that the suction capability was poor.

• Brand Name: COBLATION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC., ENDOSCOPY DIVISION; 76 south meridian avenue; oklahoma city OK 73107
• MDR Report Key: 7560441
• MDR Text Key: 109784399
• Report Number: 7560441
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

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 Model Number: EICA5872-01
• Device Catalogue Number: EICA5872-01
• Device Lot Number: 2007281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11 YR