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

Model Number 0279401200

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 09/12/2022

Event Type  Injury  

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 patient was burned.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: patient burned 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 reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

Event Description

It was reported that the patient was burned.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15620621
• MDR Text Key: 301895102
• Report Number: 0002936485-2022-00590
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057034
• UDI-Public: 07613327057034
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 0279401200
• Device Catalogue Number: 0279401200
• Device Lot Number: NR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 11/28/2022
• 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 Outcome(s): Other