MAUDE Adverse Event Report: INVUITY, INC. / STRYKER INSTRUMENTS INVUITY PHOTONSABER Y - HANDHELD ILLUMINATOR WITH ASPIRATION; CATHETER AND TIP, SUCTION

Model Number	00816728020455
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Invuity photonsaber y - handheld illuminator with aspiration device was connected prior to the start of the procedure.Product was holstered correctly, but the patient sustained a 1 cm blister/burn to the left inner thigh.The area that heated up to cause blister is where the light cord connects to the lighted suction.Another photonsaber was swapped out and used, so the photonsaber that caused the blister was never used during the procedure.With the defective photonsaber, staff were unable to replicate the conditions that led to the heating up of the connection at the base of the handle to the light cord.The light cord was also pulled from the procedure and checked for any malfunction.The light cord was not found to have any issues.Fda safety report id# (b)(4).

• Brand Name: INVUITY PHOTONSABER Y - HANDHELD ILLUMINATOR WITH ASPIRATION
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): INVUITY, INC. / STRYKER INSTRUMENTS; san francisco CA 94107 2350
• MDR Report Key: 13059815
• Report Number: MW5106194
• Device Sequence Number: 3912217
• Product Code: JOL
• UDI-Device Identifier: 00816728020455
• UDI-Public: 00816728020455
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: 00816728020455
• Device Catalogue Number: ES2Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White