MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PHOTONGUIDE ADAPT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PHOTONGUIDE ADAPT
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the customer, the device burned a patient during a procedure.The patient required further reconstructive surgery to repair burned skin.Additional information has been requested from the user facility.
Additional Manufacturer Narrative
Correction: follow-up report submitted to document the device was not available for evaluation.H3 other text : device not returned.
Event or Problem Description
Per the customer, the device burned a patient during a procedure.The patient required further reconstructive surgery to repair burned skin.Upon follow up, the user facility was not able to provide any further information regarding the reported event.

• Brand Name: PHOTONGUIDE ADAPT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16101609
• Report Number: 3015967359-2023-00010
• Device Sequence Number: 12308559
• Product Code: GEI
• UDI-Device Identifier: 00816728021315
• UDI-Public: 00816728021315
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K162053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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 Model Number: PHOTONGUIDE ADAPT
• Device Catalogue Number: PGA1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown