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

Model Number HAR36

Device Problems Material Separation (1562); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The jaw, blade and contact rings appear to be intact.Damage to the teflon pad was observed.Portion of the teflon pad tip was detached and not returned.The teflon pad t-rail was not lifted from the shaft arm.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.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported that after the procedure, the teflon pad tip was noticed as breaking away from the harmonic scalpel (har36).It did not fall off in the patient and the teflon pad was reported as still attached to the jaw.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: 7140667
• MDR Text Key: 95911531
• Report Number: 0001056128-2017-00148
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)180920(10)7139664
• 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: 12/21/2017

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: 09/20/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 7139664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• 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