MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SERFAS ENERGY 90-S CRUISE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 0279401200

Device Problems Device Remains Activated (1525); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the device continuously activated resulting in a patient burn.It should be noted that the burn was too minor to stage and did not require any additional treatment which is why we do not consider this a serious injury.

Event Description

It was reported that the device continuously activated resulting in a patient burn.It should be noted that the burn was too minor to stage and did not require any additional treatment which is why we do not consider this a serious injury.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: continuous activation resulting in burn.Probable root cause: heat can result from insufficient suction which can result from: * inadequate hospital suction, leak, bad connection to hospital suction line, * clogging caused by suction path blockage, lower electrode mass due to variation in electrode thickness or opening cut use error the device manufacture date is not known the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: SERFAS ENERGY 90-S CRUISE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16096914
• MDR Text Key: 307155085
• Report Number: 0002936485-2023-00001
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057034
• UDI-Public: 07613327057034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0279401200
• Device Catalogue Number: 0279401200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 02/16/2023
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male