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

Model Number HAR36

Device Problems Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions for evaluation.Inspection of the returned device revealed evidence of clinical use including biological material on the distal tip and indention in the teflon pad.The shaft rotation and the jaw actuation of the device were found to be acceptable.The device was connected to generator and passed the initial testing.The foot pedals and min button were able to activate the device, but the max button would not activate the device.The device was able to successfully activate with the foot pedals and min button, and at no time did the device fail to activate or stop working, produce an error code or emit any adverse noise.The membrane switch assembly (msa) was tested, and the max button failed.Inspection of the msa revealed signs of dried fluid in the handle and underneath the max button pad.The device was examined further and a build up of tissue/fluid was noticed along the rod.The rod was inspected for fractures, and none were found.The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid to rise up the rod into the handle.The cause of tissue/fluid build up is damage to the distal gasket; action is being taken to address this issue.Tissue build up due to distal gasket damage can disrupt harmonic frequency and potentially reduce cutting ability; therefore, the reported complaint was confirmed.

Event Description

It was reported that the generator for the har36 ultrasonic scalpel displayed a reactivate error message.The device was retested numerous times but would not pass testing.There was no medical intervention or adverse consequences reported.Surgical delay was minimal to replace the device.The procedure was completed successfully.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake drive; tempe AZ 85283
• 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: 4940274
• MDR Text Key: 22890311
• Report Number: 0001056128-2015-00068
• 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: Nurse
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 3332951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2014
• 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