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

Model Number 10-401FC

Device Problem Material Fragmentation (1261)

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

Event Date 05/15/2020

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.

Event Description

It was reported that during a procedure involving the myosure reach, the device malfunctioned and the physician observed the cutting blade outside of the device on the monitor.The myosure reach was removed with the blade still attached to the device, no fragments were left in the patient.A new myosure reach disposable was unpackaged and used to successfully complete the biopsy procedure.There was no impact to patient health or injury to the end user.

• Brand Name: MYOSURE REACH TISSUE REMOVAL DEVICE
• Type of Device: UTERINE 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: 10101411
• MDR Text Key: 193658701
• Report Number: 1222780-2020-00083
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 25420045504537
• UDI-Public: (01)25420045504537(10)20A28RS(17)230128
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K152723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 20A28RS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• 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