MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE+7 SHEARS; SCALPEL, ULTRASONIC, REPROCESSED

Catalog Number HARH36

Device Problem Device Inoperable (1663)

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

Event Date 03/12/2018

Event Type  malfunction  

Event Description

Harmonic scalpel did not function.Would not assume the ready mode.Persistently flagged to "tighten assembly" several times.Despite re-tightening, it did not work.Another harmonic scalpel was obtained that functioned.

• Brand Name: HARMONIC ACE+7 SHEARS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 5300 region ct; lakeland FL 33815
• MDR Report Key: 7475543
• MDR Text Key: 106994138
• Report Number: 7475543
• 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: 04/13/2018,04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/29/2021
• Device Catalogue Number: HARH36
• Device Lot Number: 8000665
• Other Device ID Number: 5MM DIAMETER X 36MM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2018
• Event Location: Other
• Date Report to Manufacturer: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO.