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

Model Number 5DCS

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.The device was damaged by the carrier and was unable to be delivered.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event may be attributed to: failure mode: damage to the instrument or the insulation.Use error: user attempts to cut excessive amount of tissue.Damaged insulation due to misuse, including improper insertion to / withdrawal from a trocar.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.Should the device become available for return, the investigation will be reopened.

Event Description

It was reported that the insulation broke off from the laparoscopic scissors during procedure.The insulation fell into the patient and was not retrieved.There was no patient injury, medical intervention or extended procedure time reported.These are commonly used devices that are readily available.

Manufacturer Narrative

A review of mdrs filed since may 20, 2019, through september 2, 2022, was conducted.Since august 17, 2020, there have been no additional reports of serious injury or surgical intervention to preclude serious injury or permanent impairment related to this specific failure mode.Based on the analysis of mdr data compared to the firm¿s sales figures, the likelihood of this specific failure mode causing or contributing to another serious injury should the malfunction occur is considered remote.As such, we will no longer be reporting for the failure mode of laparoscopic (lap) broken and detached shaft pin region components.

Event Description

It was reported that the insulation broke off from the laparoscopic scissors during procedure.The insulation fell into the patient and was not retrieved.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; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 10544229
• MDR Text Key: 207303313
• Report Number: 0001056128-2020-00065
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: 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,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Device Lot Number: 11889254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2020
• 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 Outcome(s): Other