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

Model Number	7210111
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the electrode head fell off into the knee joint cavity.There was a backup device available to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
An evaluation was performed by smith & nephew and could confirm the customer complaint for the electrode head fell off.A visual inspection was performed and showed the probe is in very poor condition.The top electrode is detached from the probe.Under microscopic inspection the electrode shows to be bent on one side where it broke free indicating a force was applied to the tip.The insulation at the tip of the probe is damaged by contact.The return plate shows heavy scratches in the metal indicating a hard force was applied.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.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: 7723302
• Report Number: 3003604053-2018-00117
• Device Sequence Number: 19149845
• Product Code: GEI
• UDI-Device Identifier: 03596010481498
• UDI-Public: (01)03596010481498(17)200524(10)1191428
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: 7210111
• Device Catalogue Number: 7210111
• Device Lot Number: 1191428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1