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

Model Number HARH36

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2018

Event Type  malfunction  

Event Description

Stryker harmonic scalpel not recognized by system twice.A third device was obtained and worked without incident.There was no harm to the patient.During hook up, the issue was discovered.

• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region ct; lakeland FL 33815
• MDR Report Key: 7973648
• MDR Text Key: 123984736
• Report Number: 7973648
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HARH36
• Device Catalogue Number: HARH36
• Device Lot Number: 8756136
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2018
• Date Report to Manufacturer: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA