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

Model Number	EICA8872-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Coblator wand was used for surgery and part of the small metal tip broke off.Device was removed from sterile field and replaced.No harm came to the patient, and small metal tip was suctioned away.Device was given to operating room material's management staff who managed a return of the device.It was noted that a similar event occurred earlier in the week.Both devices have been added to this report, although it is unclear which lot number corresponds with this patient and event.

• Brand Name: COBLATION
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9888277
• Report Number: 9888277
• Device Sequence Number: 2437348
• Product Code: GEI
• UDI-Device Identifier: 00817470009743
• UDI-Public: (01)00817470009743
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2020
• Report Date (Section F): 02/18/2020

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 Model Number: EICA8872-01
• Device Catalogue Number: EICA8872-01
• Device Lot Number: 2041710
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 61
• Date Report Sent to FDA: 02/18/2020