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

Model Number	5DCS
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.The returned complaint device was received open with the original stryker sustainability solutions packaging label.Inspection of the insulation revealed damage 2 mm and 9 mm from the distal tip.Inspection found to show wear and damage on the shaft insulation that starts at the distal tip and ends 10 mm up the shaft.Inspection of the jaws found debris from clinical use.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - failure mode: damaged shaft.- use error: user sets the power output to higher setting.- failure mode: damage to the instrument or the insulation.- use error: user improperly manipulates device through the cannula.- use error: user selects incompatible size cannula/device.- failure mode: poor fit of device into cannula causes user to exert excessive force during insertion.- failure mode: shaft insulation surface is too rough.The instructions for use (ifu) state: - 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.- do not introduce or withdraw the instrument through a trocar sleeve with the blade/jaws open.- the instrument will operate with electrosurgical generators having a high frequency maximum voltage of 3000 volts peak.Ensure that all safety precautions are followed and refer to the electrosurgical generator¿s specification to verify compatibility and for indications and instructions.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that when using the scissor for cautery through a trocar grip cannula the patient jumped with activation.The instrument was removed and it was noted that there was insulation missing and exposed metal on instrument shaft.The cannula was removed.Irrigation with nacl 0.9% and tissue assessment was performed.It was noted that little black fragments off instrument were left inside the patient.The customer was not able to provide additional information, however, there was no patient injury reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
"type of reportable event" was corrected from malfunction to serious injury to reflect the reported event information.
Event or Problem Description
It was reported that when using the scissor for cautery through a trocar grip cannula the patient jumped with activation.The instrument was removed and it was noted that there was insulation missing and exposed metal on instrument shaft.The cannula was removed.Irrigation with nacl 0.9% and tissue assessment was performed.It was noted that little black fragments off instrument were left inside the patient.The customer was not able to provide additional information, however, there was no patient injury reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6819490
• Report Number: 0001056128-2017-00112
• Device Sequence Number: 138831
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288(17)190211(10)4356839
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2019
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Device Lot Number: 4356839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 111