MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PHOTONSABER Y, BULB TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ES1Y
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, when opening the package the tip was found to be broken off.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Additional mfg narrative: update: d9, h3, h6 device evaluation: follow-up report submitted to document the device evaluation.Correction: d2b product code updated.
Event or Problem Description
Per the customer, when opening the package the tip was found to be broken off.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: PHOTONSABER Y, BULB TIP
• 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: 17438734
• Report Number: 3015967359-2023-01758
• Device Sequence Number: 19494974
• Product Code: JOL
• UDI-Device Identifier: 00816728020462
• UDI-Public: 00816728020462
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ES1Y
• Device Lot Number: 98399524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown