MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE ROD LENS HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 40-200

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

Device identifier : (b)(4).D4: lot and 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 disposable device as the identification numbers were not provided by the complainant.H3: 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.

Event Description

It was reported that during an myosure hysteroscope procedure the power supply cord was too close to the patient and it sustained a burn to the leg.The burn was described as deep partial thickness on the left thigh.Silvadene cream and sterile dressings were applied to the burn site and a dermatology follow up was scheduled.The size was approximately 1cm by 1cm.No other information is available.

• Brand Name: MYOSURE ROD LENS HYSTEROSCOPE
• Type of Device: 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: daniel guevara ; 562 parkway; coyol free park zone b24; san jose 20102 ; CR 20102
• MDR Report Key: 19101743
• MDR Text Key: 340101966
• Report Number: 1222780-2024-00153
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 40-200
• Device Catalogue Number: 40-200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other