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

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Reset Problem (3019)

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

Event Date 01/24/2017

Event Type  malfunction  

Event Description

The reprocessed shears caused a problem with the generator which required manual reset very often during the procedure.This usually happens when the shears are being applied to an area of bleeding tissue when cautery energy is most needed.Harmonic ace shears were replaced with the advanced hemostasis which performed without issue for the remainder of the case.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 6328408
• MDR Text Key: 67566835
• Report Number: 6328408
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: HAR36
• Device Lot Number: 5449203
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 73