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

Model Number HARH23

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The front end of the teflon pad tip was detached.The teflon pad was not lifted from the shaft arm.The missing teflon pad tip was not returned with the complaint device.The jaw, blade 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: - incidental contact with device and external instrument causing damage to the tissue pad - too much force or torque applied to instrument, or grasping/pulling - applying pressure between instrument blade and tissue pad without having tissue between them 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.- do not introduce or withdraw the instrument with the jaws open through a trocar sleeve as this may damage the instrument.- keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad and increased blade, clamp arm and distal shaft temperatures.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the plastic on the jaws is coming off the harmonic scalpel (harh36).This was noted prior to patient use, but the device was used for a period of time and then replaced.Nothing fell into the patient.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

Manufacturer Narrative

Model # was corrected from harh36 to harh23 to reflect the reported lot number and returned device.This correction changes the model number but does not change the mdr reportability status.The only difference between harh36 and harh23 is the length of the shaft, 36cm versus 23cm.The device functionality and capabilities are identical.

Event Description

It was reported the plastic on the jaws is coming off the harmonic scalpel.This was noted prior to patient use, but the device was used for a period of time and then replaced.Nothing fell into the patient.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

Manufacturer Narrative

This supplemental mdr #2 serves to correct the "reportability awareness date" for supplemental mdr #1 from 01/09/2018 to 02/05/2018.The correct awareness date of 02/05/2018 is when the post-market surveillance data analyst became aware of the model # discrepancy, found through the ¿mdr reference list updated 02.05.2018¿ spreadsheet.The information was immediately verbally notified to the regulatory compliance specialist.This correction verifies that the supplemental mdr #1 was submitted within fda timeline regulations based on true awareness date.This correction does not change the mdr reportability status.

Event Description

It was reported the plastic on the jaws is coming off the harmonic scalpel.This was noted prior to patient use, but the device was used for a period of time and then replaced.Nothing fell into the patient.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: 7194842
• MDR Text Key: 97877567
• Report Number: 0001056128-2018-00006
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327346251
• UDI-Public: (01)07613327346251(17)200926(10)7192481
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: HARH23
• Device Catalogue Number: HARH36RR
• Device Lot Number: 7192481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• 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