MAUDE Adverse Event Report: HOLOGIC, INC 3.7MM DIAGNOSTIC SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	60-201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a hysteroscopy dilation and curettage (d&c), the physician was having difficulty dilating the cervix and created a false passage.A yellow appearing tissue consistent with bowel was observed on display, indicating a posterior perforation.The procedure was aborted and a bariatric surgeon was called in for further assistance.No other information is available.
Additional Manufacturer Narrative
Lot number/serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

• Brand Name: 3.7MM DIAGNOSTIC SHEATH
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: simran keswani ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 24985924
• Report Number: 1222780-2026-00184
• Device Sequence Number: 10491164
• Product Code: HIH
• UDI-Device Identifier: 15420045510265
• UDI-Public: 15420045510265
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: K182006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 60-201
• Device Catalogue Number: 60-201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 60-200.
• Patient Sex: Unknown