MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE REACH TISSUE REMOVAL DEVICE; UTERINE HYSTEROSCOPIC DEVICE

Model Number 10-401FC

Device Problem Metal Shedding Debris (1804)

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

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.(b)(4).

Event Description

It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2017, and during the procedure it was noted there were metal particles in the uterus.The physician "tried to flush out with saline but without luck.Gynecologist thought it is too small to cause problems in the future.It was reported that there was no harm to the patient".

Manufacturer Narrative

The returned device was received and visually inspected on february 15, 2020.The device arrived with the blade frozen due to residual biological built up on device and in the closed position.Pmqa dissected device to free blade tube manually from outer metal tube to continue investigation.Visual examination of the unit noted minor damages on the cutting blade and a scribe mark on the cutting window which is indicative of the blade exiting the cutting window during procedure.It has been determined that this is most likely due to the technique implemented by the end user during the operation; excessive forces applied during tissue acquisition may result in device failure.No significant fragmentation of the blade was noted.It cannot be determined whether the small amount of damage to blade resulted in same material viewed in patient cavity as no missing fragments were observed on the returned unit.Device history record (dhr) review was conducted for the reported identification number.The lot 17c31r was released meeting all qa specifications.

• Brand Name: MYOSURE REACH TISSUE REMOVAL DEVICE
• Type of Device: UTERINE HYSTEROSCOPIC DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 7152419
• MDR Text Key: 96127409
• Report Number: 1222780-2017-00299
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K100559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 17C31R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• 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