MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; SCALPEL, ULTRASONIC, REPROCESSED

Catalog Number HARH36

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Detachment Of Device Component (1104); Component Falling (1105); Device Operates Differently Than Expected (2913)

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

Event Date 11/17/2017

Event Type  malfunction  

Event Description

Two reprocessed harmonic scalpels malfunctioned.The white portion of the mouth piece on one fell off and is charred, the other is completely burned.A third was opened - it was an extra long.There was no issue with the third.There was no patient harm.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake dr; tempe AZ 85283
• MDR Report Key: 7244558
• MDR Text Key: 99134256
• Report Number: 7244558
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018,01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: HARH36
• Device Lot Number: 7071133 AND 7098477
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 60 YR