MAUDE Adverse Event Report: HOLOGIC, MARLBORUGH MA MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.Serial number of the myosure control unit and hysteroscope not provided by the complainant.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was not able to be conducted for the myosure system as the identification numbers were not provided by the complainant.Event problem and evaluation codes: the device was received and gross visual examination of the return product revealed evidence of a blade exit during procedure.The distal tip was bent backwards there was strike marks and fragmented damage to the blade.This type of finding appears to be user related.Devices are also 100% visually inspected for blade damage prior to final release.This observation will be monitored and trended.Reference internal complaint (b)(4).

Event Description

It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2017 and when pressure was placed on the disposable device the top bent and part of the blade broke off inside the patient.The physician removed the piece and completed the procedure.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, MARLBORUGH MA; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6525589
• MDR Text Key: 74020173
• Report Number: 1222780-2017-00103
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 10-401
• Device Lot Number: UNKHOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MYOSURE CONTROL UNIT-SERIAL # UNK; MYOSURE HYSTEROSCOPE-SERIAL # UNK