MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE XL ROD LENS HYSTEROSCOPE

Model Number 50-250XL

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

Myosure xl hysteroscope s/n (b)(4) was "sent to a local company for assessment/cleaning." there is no statement if the hologic ifu is being followed in order to properly clean the device.If scopes are cleaned according to the manufacturer's instructions, there should be no "debris" present in the working channel of the hysteroscope.Hysteroscopes must be cleaned after each procedure in accordance with the ifu.Third party analysis of the suspect device reported that myosure xl hysteroscope serial number (b)(4) was returned clean with no debris found in the working channel.No device problem was observed.

Event Description

Limited information was reported by the user facility on (b)(6) 2016.The user facility reported the myosure xl hysteroscope had "fleshy particles lodged inside" the working channel of the hysteroscope.There was no patient injury.No additional information forthcoming.

• Brand Name: MYOSURE XL ROD LENS HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, ma
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, ma
• Manufacturer Contact: david ramsay ; 250 campus drive; marlborough, ma ; 2638713
• MDR Report Key: 6373151
• MDR Text Key: 196232300
• Report Number: 1222780-2016-00309
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2016

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 Operator: Health Professional
• Device Model Number: 50-250XL
• Device Catalogue Number: 50-250XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female