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

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/23/2020

Event Type  malfunction  

Event Description

Whilst using reprocessed harmonic handpiece har9f, the minimum button was sticking and going off when nobody was touching the handpiece.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 9995157
• MDR Text Key: 188826952
• Report Number: 9995157
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: (01)07613327348248(17)221216(10)11355289
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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: HAR9F
• Device Lot Number: 11355289
• 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: 04/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 87