MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP T7 HOOD W ANTI-REFLECTIVE LENS; HOOD, SURGICAL

Catalog Number	0416800200
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 3 malfunction events in which the device had debris in sterile package.3 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events.3 events were reported for this quarter.Product return status.1 device was not available for evaluation.2 device investigation types have not yet been determined.Additional information.3 devices were labeled for single-use.3 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device had debris in sterile package.3 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale.Corrected data: h6, h10.3 previously reported events are included in this follow-up record.Product return status: 3 devices were not available for evaluation.H3 other text : device not returned.

• Brand Name: T7 HOOD W ANTI-REFLECTIVE LENS
• Common Device Name: HOOD, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17992854
• Report Number: 3015967359-2023-02277
• Device Sequence Number: 17989136
• Product Code: FXY
• UDI-Device Identifier: 37613327466684
• UDI-Public: 37613327466684
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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 Catalogue Number: 0416800200
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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