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

Model Number	5DCS
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 10365653
• Report Number: 0001056128-2020-00055
• Device Sequence Number: 2865532
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: 00885825013288
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention