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

Model Number HAR36

Device Problems False Alarm (1013); Loss of Power (1475); Device Stops Intermittently (1599)

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

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned to (b)(4) for evaluation.Inspection of the returned device revealed evidence of clinical use including excessive biological material on the distal tip and an indention in the teflon pad.During investigation, 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.Tissue build up due to distal gasket damage can disrupt harmonic frequency and potentially reduce cutting ability.The reported event will continue to be monitored through post market surveillance.

Event Description

It was reported that har36 device had either intermittent signals, false alarms, or shut off.There was no patient injury or medical intervention, and extended procedure time reported was minimal.

• 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: 5109439
• MDR Text Key: 27019437
• Report Number: 0001056128-2015-00085
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 08/21/2015

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: 07/31/2016
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 3782097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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