MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION FLOW 90 WAND; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 72290038

Device Problem Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2019

Event Type  malfunction  

Event Description

Left shoulder arthroscopic subacromial decompression, distal clavicle excision and open biceps tenodesis.Orthopedic surgeon using the smith and nephew coblation werewolf machine with foot pedal with the ward inside the patient's shoulder when the wand would not shut off.Orthopedic surgeon stated, "the wand will not shut off" and then the smith and nephew rep and circulating nurse went to the machine and dismantled the wand off the machine and orthopedic surgeon removed the wand from the shoulder.A new wand was opened and worked fine with no problems.The machine and foot pedal went to biomed and the ablation wand and original packing went to central supply director.The defective wand smith and nephew werewolf flow 90 coblation wand ref # 72290038, lot # 2034129, exp.2021-05-24.Manufacturer response for smith and nephew werewolf flow 90 coblation wand, smith and nephew werewolf flow 90 coblation wand (per site reporter).

• Brand Name: FLOW 90 WAND
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 150 minuteman rd; andover MA 01810
• MDR Report Key: 9190899
• MDR Text Key: 162346400
• Report Number: 9190899
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2019,09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72290038
• Device Catalogue Number: 72290038
• Device Lot Number: 2034129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA