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

Model Number	EICA8872-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Procise xp wand was used for tonsillectomy when user noticed tip of wand missing after use.Small piece was suctioned by surgeon, with no harm to the patient and no additional follow up needed.The product was kept and will be returned for failure analysis.Manufacturer response for electrosurgical, cutting coagulation accessories, coblation (per site reporter).Material's management for the or notified the manufacturer.An ra was provided and the device was returned for failure analysis.

• Brand Name: COBLATION
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 9943344
• Report Number: 9943344
• Device Sequence Number: 3374854
• 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): 02/04/2020
• Report Date (Section F): 02/04/2020

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: 2039037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2020
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 25
• Date Report Sent to FDA: 02/04/2020