MAUDE Adverse Event Report: GYRUS ACMI, INC Gyrus ACMI; Hysteroscope (And Accessories)

Model Number	RAC-B
Medical Device Problem Codes	Material Fragmentation (1261); Explosion (4006)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument "pop" and saw plastic floating through the air.

• Brand Name: Gyrus ACMI
• Common Device Name: Hysteroscope (And Accessories)
• Manufacturer (Section D): GYRUS ACMI, INC; 2925 appling rd; bartlett TN 38133
• MDR Report Key: 50838205
• Report Number: 50838205
• Device Sequence Number: 21319517
• Product Code: HIH
• UDI-Device Identifier: 00821925007437
• UDI-Public: (01)00821925007437
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026
• Report Date (Section F): 09/02/2026

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: RAC-B
• Device Catalogue Number: RAC-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/16/2026