MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number 5DCS

Device Problem Failure to Cut (2587)

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot number and/or serial number was not reported.The reported event could be attributed to: user attempts to cut staples or clips, user attempts to cut non-soft tissue, user attempts to cut excessive amount of tissue.The instructions for use (ifu) state: do not apply electrosurgical current directly to clips and/or staples.If cutting of staples or clips is attempted, damage to the instrument may occur.A complete understanding of the principles and techniques involved in laser, electrosurgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to other medical instruments.Ensure that insulation or grounding is not compromised.Do not immerse electrosurgical instruments in liquid.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

Event Description

It was reported the laparoscopic scissors (5dcs) are dull.No other information is available by the facility.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• 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: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 7140444
• MDR Text Key: 95931727
• Report Number: 0001056128-2017-00146
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110189
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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