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

Model Number 7210111

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopic shoulder surgery, the saphyre probe had an electrical leakage, there were sparks.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.

• Brand Name: PROBE,SAPHYRE II, 90DEG,3MM,SUCTION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15996471
• MDR Text Key: 308203579
• Report Number: 3003604053-2022-00070
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 03596010481498
• UDI-Public: 03596010481498
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210111
• Device Catalogue Number: 7210111
• Device Lot Number: 2071708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1