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

Model Number HAR36

Device Problems Fire (1245); Melted (1385)

Patient Problem No Code Available (3191)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use and an indention on the teflon pad was identified.The device inspection indicated that the complaint was not confirmed for the reported failure mode.Three attempts were made to the customer to clarify what was meant by ¿fire¿, and no response was received.It was reported that the patient was not burned or harmed in any way.The teflon pad was observed to be attached to the jaw assembly and exhibit normal degrees of wear that occurs with use of the device.No burn or smoke residue was observed on the teflon pad.The results of the functional testing performed determined that the reported event was not confirmed.The device was noticed to have tissue/fluid buildup between the blade and shaft assembly.The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid/tissue to rise up the rod.A review of the dhr supports that the device met all inspection and test criteria prior to release.The causes of distal gasket damage are undetermined at this time; preventative measures have been taken to prevent the escape of any product exhibiting this failure mode.Therefore, the potential root cause is damage to the distal gasket subsequent to distribution at customer site.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." ¿care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.If this occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message." " the instruments allow for the coagulation of vessels up to and including 5mm in diameter.Do not attempt to seal vessels in excess of 5mm in diameter." ¿select the desired minimum power level using the increase and decrease buttons on the generator touchscreen.Note: the recommended minimum starting power level is level 3.For greater tissue cutting speed use a higher generator power level, and for greater coagulation use a lower generator power level.The amount of energy delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade characteristics, grip force, tissue tension, tissue type pathology, and surgical technique.¿ the reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the teflon pad of the harmonic scalpel melted and caused a fire inside the patient.The patient was not burned or harmed in any way.There was no 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: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 5737152
• MDR Text Key: 48665046
• Report Number: 0001056128-2016-00082
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 4062099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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