MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE, SAPHYRE II, 90DEG, 3MM, SUCTION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	7210111
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a surgery, the device front material fell off.All pieces were removed.The reported delay result in a little extended exposure to anesthesia to the patient.A back-up device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
An evaluation was performed by smith and nephew and could confirm the customer complaint for the material fell off the device.A visual inspection was performed under microscope inspection and showed the insulation is damaged at the tip.This damage is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: PROBE, SAPHYRE II, 90DEG, 3MM, SUCTION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8131360
• Report Number: 3003604053-2018-00188
• Device Sequence Number: 16577319
• Product Code: GEI
• UDI-Device Identifier: 03596010481498
• UDI-Public: 03596010481498
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K991218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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 Expiration Date: 04/30/2020
• Device Catalogue Number: 7210111
• Device Lot Number: 1189951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR