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

Model Number HAR36

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned to (b)(4) for evaluation.During visual inspection, the distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid/tissue to rise up the rod.The device did not operate as a result of a build up of fluid/tissue along the distal end of the inner rod.A review of the device history record indicates the device met all inspection and test criteria prior to release.The potential root cause is damage to the distal gasket subsequent to distribution at customer site (e.G.Tissue impaction through use).The instructions for use (ifu) states: "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.".

Event Description

It was reported the device would not seal and the patient bled but did not require a blood transfusion.There was no patient injury, medical intervention, and extended procedure time reported was minimal.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: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 5520590
• MDR Text Key: 41254107
• Report Number: 0001056128-2016-00029
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2016
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 4209771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2015
• 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
• Patient Age: 48 YR