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

Model Number N/A

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

The jaws of harmonic ace®+7 shears with advanced hemostasis would not close.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 10626205
• MDR Text Key: 209779056
• Report Number: 10626205
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HARH36
• Device Lot Number: 11554890
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1