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

Model Number HAR36

Device Problem Failure to Cut (2587)

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

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, an indentation in the teflon pad and evidence of clinical use was identified.Inspection of the contact ring revealed no damage.The device was disassembled and cleaned, and the blade was inspected for cracks with a microscope.A fracture was found near the pinhole.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.Therefore, the most likely root cause is excessive force applied by the torque wrench due to mishandling subsequent to distribution from stryker.The instructions for use (ifu) state: avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the harmonic scalpels would not cut and the devices were replaced.There was no patient injury, medical intervention, and extended procedure time reported was minimal.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 5721517
• MDR Text Key: 48200551
• Report Number: 0001056128-2016-00078
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 4368730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1