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

Model Number HAR36

Device Problem Device Alarm System (1012)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

It was reported that during the procedure the generator of the ultrasonic scalpel alarmed, "relax pressure on blade." the alarm occurred three times, and the facility examined and reset the device each time.There was no medical intervention, surgical delay, or adverse consequences to the patient.The procedure was completed successfully.

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 an 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 an generator using the appropriate hand piece.The scalpel was tested and failed with two "tighten assembly" errors (after which the assembly was tightened) and a "replace instrument" error.The device was examined further, and a build up of dried fluid was noticed along the rod.The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip.The rod was inspected for fractures, and a crack as well as gouges in the blade were observed.A review of the device history record indicates the device met all inspection and test criteria prior to release.The most likely root cause of a cracked blade is activating the device on a surgical clip or staple.The reported event will continue to be monitored through post-market surveillance.The instructions for use state: "avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.".

• 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: 4714088
• MDR Text Key: 5649990
• Report Number: 0001056128-2015-00028
• 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
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 3485180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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