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

Model Number 5DCS

Device Problem Temperature Problem (3022)

Patient Problem Bowel Burn (1756)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.The complainant facility will not be releasing the device.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: use error: user activates device for a prolonged period of time.Failure mode: current leakage due to shaft damage.Use error:user places patient return electrodes too far from the surgical site.Use error:user positions patient incorrectly creating skin-to-skin contact points (e.G.Fingers touching leg).Use error: accidental activation of device.The instructions for use (ifu) state: ensure the blades/jaws are fully visible to avoid inadvertent tissue damage, when using electrocautery.Instruments with monopolar cautery are not to be used as bipolar cautery instruments.Do not apply electrosurgical current directly to clips and/or staples.Inspect the site for hemostasis after removing the instrument.If hemostasis is not present, use appropriate techniques to attain hemostasis.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 laparoscopic scissors were being used to remove the tissue around the uterus.The end of the scissors got too hot.As they were removing the uterus the dr.Noticed there was a burn on the colon.He did have to suture it to ensure it was reinforced.The burn was attributed to the stryker device and the physician sutured the burn to prevent further injury.There was a mark on the scissors from the heat and the colon.There was no extended procedure time reported.The complainant is not aware of any additional adverse consequences.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: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 10365653
• MDR Text Key: 201659636
• Report Number: 0001056128-2020-00055
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Device Lot Number: 11645460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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): Required Intervention