MAUDE Adverse Event Report: Hologic, Inc. CoolSeal¿ Reveal; Electrosurgical, cutting coagulation accessories

Model Number	CSL-RV105-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Disposable cool seal trigger broke off.

• Brand Name: CoolSeal¿ Reveal
• Common Device Name: Electrosurgical, cutting coagulation accessories
• Manufacturer (Section D): Hologic, Inc.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 50754740
• Report Number: 50754740
• Device Sequence Number: 18440432
• Product Code: GEI
• UDI-Device Identifier: 00850346007092
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/08/2026
• Report Date (Section F): 07/08/2026

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
• Device Model Number: CSL-RV105-10
• Device Catalogue Number: CSL-RV105-10
• Device Lot Number: 26D24Rg
• 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: 09/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/08/2026