MAUDE Adverse Event Report: HOLOGIC MYOSURE ROD LENS HYSTEROSCOPE

Catalog Number 40-250

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 03/27/2015

Event Type  Injury  

Event Description

It was reported that during a myosure for uterine tissue removal procedure on (b)(6) 2015, the myosure hysteroscope was "left touching the patient's leg" and the "patient did get burned".It is unknown if intervention was required.We have been unable to obtain additional information surrounding this event.

Manufacturer Narrative

The myosure hysteroscope is not being returned, therefore, a failure analysis of the myosure hysteroscope cannot be completed.Device history record (dhr) review was not able to be conducted for the myosure hysteroscope as product identification numbers were not provided by the complainant.If additional relevant information received, a supplemental medwatch will be filed.Reference internal complaint cc# (b)(4).

• Brand Name: MYOSURE ROD LENS HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan, qa mgr ; 250 campus drive; marlborough, MA 01752 ; 5085368859
• MDR Report Key: 4741752
• MDR Text Key: 5775272
• Report Number: 1222780-2015-00073
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2015

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 Catalogue Number: 40-250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/23/2015
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM,; CONTROL UNIT, SN UNK. MYOSURE TRD, LOT # UNK.
• Patient Outcome(s): Other