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

Model Number HARH36

Device Problems Thermal Decomposition of Device (1071); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.The facility stated that the device will not be released at this time.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot number and serial number were not reported.The reported event could be attributed to the following: ancillary equipment issues (e.G.Handpiece, generator).Tissue accumulation between the blade and shaft and/or blade and jaw assembly.Activation against solid surfaces, repeated use of instrument beyond intended use.Applying pressure between instrument blade and tissue pad without having tissue between them.Prolonged activation.The instructions for use (ifu) state: 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.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.Note: do not touch the instrument to metal while activated.Note: do not clean the blade tip with abrasives.It can be wiped with a moist gauze sponge to remove tissue, if necessary.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.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened at that time.

Event Description

It was reported a piece of burnt teflon pad fell off the harmonic scalpel (har36).The piece of the teflon pad fell into the patient but was retrieved with a grasper.The delay was estimated at 5 to 10 minutes to retrieve the piece and replace the device.There was no patient injury or medical intervention and extended procedure time reported was minimal.These are commonly used devices that are readily available.

Manufacturer Narrative

Model # was corrected from har36 to harh36 to reflect the additional information containing lot number.This correction changes the model number but does not change the mdr reportability status.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported a piece of burnt/charred teflon pad fell off the harmonic scalpel.The piece of the teflon pad fell into the patient but was retrieved with a grasper.The delay was estimated at 5 to 10 minutes to retrieve the piece and replace the device.There was no patient injury or medical intervention and extended procedure time reported was minimal.These are commonly used devices that are readily available.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions after the initial mdr and supplemental 1 was filed.Visual inspection revealed evidence of clinical use.The teflon pad was identified to be melted and detached from the jaw.The teflon pad was returned with the complaint device.The jaw, blade and contact rings appear to be intact.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported a piece of burnt/charred teflon pad fell off the harmonic scalpel.The piece of the teflon pad fell into the patient but was retrieved with a grasper.The delay was estimated at 5 to 10 minutes to retrieve the piece and replace the device.There was no patient injury or 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: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 7140408
• MDR Text Key: 95868528
• Report Number: 0001056128-2017-00143
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 885825017347
• UDI-Public: (01)885825017347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161693
• 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,Followup,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2018
• Device Model Number: HARH36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 7071133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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