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

Model Number HAR36

Device Problems Device Ingredient or Reagent Problem (2910); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2015

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 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 could allow fluid to rise up the rod.No tissue build up was observed on this device; however, 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 the har36 ultrasonic scalpel was not coagulating like it should.There were no error codes on generator.There was no medical intervention, surgical delay, or adverse consequences reported.The procedure was completed successfully.

• 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: 5106175
• MDR Text Key: 26956053
• Report Number: 0001056128-2015-00084
• 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: Other Health Care Professional
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 3736254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• 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