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

Model Number HAR36

Device Problems Device Inoperable (1663); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The tip of the distal end of the blade was broken off and not returned with the device.The teflon pad and contact rings appear to be intact.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: jaws/blade subassembly damage.Incidental and prolonged activation against solid surfaces, such as bone or plastic.The instructions for use (ifu) state: blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft.To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft.For optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline.If tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece.If desired, the instrument may be unplugged.Storage and handling - temperature: 18 c to 60 c.Relative humidity: 10 to 80%.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.Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.Close the trigger.Remove the torque wrench by sliding it off of the shaft.Do not dispose of the torque wrench until the procedure is completed.The torque wrench is used to remove the instrument from the hand piece following the procedure.Dispose the torque wrench only after completing the procedure.Note: take care to avoid damage to the blade and clamp arm by closing the trigger while sliding the torque wrench onto or off of the shaft.Note: take care to avoid injury from the blade tip while sliding the torque wrench onto or off of the shaft.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the button on a harmonic scalpel did not work.There was no patient injury, medical intervention, or extended procedure time reported.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: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 7517117
• MDR Text Key: 108735256
• Report Number: 0001056128-2018-00029
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)181010(10)7246849
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 7246849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• 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