MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE ROD LENS HYSTEROSCOPE; UTERINE HYSTEROSCOPE

Model Number 40-250

Device Problems Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

Serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.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.Lot number of the device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the device as the identification numbers were not provided by the complainant.

Event Description

It was reported that during the procedure, the surgeon performed a diagnostic hysteroscopy with the scope."the physician stated that she did not have a clear view.The deficit rose quickly to the facility limit of 2500cc normal saline, at which time the hysteroscopy was aborted." patient was brought back to the or several hours later for exam under anesthesia and possible laparoscopy.The hologic representative believes there was a suspected uterine perforation.No additional details available.

Manufacturer Narrative

The device was received and tested.It was noted upon visual inspection that the jacket of the drive cable was a bit damaged at the base of the handpiece and that the blade was corroded.On the other hand, the device did not perform as intended during mechanical testing since the blade did not reciprocate upon pressing the foot pedal.Once dissected, the presence of metallic flakes were confirmed on the inner and outer surface of the device and also the wire was found to be nicked.The reported observation was confirmed.The metal flakes are the result from the interaction of the inner and outer cannula once the blade is activated.The inner cannula evidenced some markings at the proximal side.This observation will be monitored and trended.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

Manufacturer Narrative

New information has been received and based on our investigation the probable root cause for the ¨metal flakes¨ is in the area where the morcellator shaft is located.The morcellator shaft consists of a stationary outer tube with a side facing cutting window and a rotating and reciprocating inner blade.This rotating and reciprocating movement in conjunction with the suction allows the myosure tissue removal device to remove the target tissue from the uterus.If any abnormal bend force is applied to the handpiece during the procedure due to an improper handling or the tissue is harder than the one that it was designed to remove, there is a possibility to cause friction between the outer tube and blade.Thus, causing erosion between the blades leading to small particles of metal being generated.The probable cause for this is due to an excessive amount of force applied to the handpiece by the physician during the procedure and the rotating movement out of abundance of caution hologic has performed a health risk assessment for myosure trd metal shavings detached from the device for a similar complaint (rsk-03638, rev 001).This assessment was performed to evaluate and assess if any new risks/harms can be introduced while using myosure trd and the presence of metal flakes.Based upon the health risk assessment performed, no injuries or deaths have been reported to hologic related to metal shavings detached from the myosure tissue removal device.The hazardous situation was reviewed by a physician and it was determined that there is a high probability that those metal fragments are flushed out of the uterus after the procedure or with the next menstrual cycle.In the worst case situation in which the fragments remain in the uterus or get flushed through the fallopian tubes and into the abdomen.These fragments are stainless steel, and this material is known to be inert and has been evaluated for biocompatibility using cytotoxicity, sensitization and intracutaneous reactivity/irritation endpoints.Thus, the risk was deemed acceptable, and no further actions are necessary.The failure mode related to metal flakes is not likely to result in a death, serious injury or to cause adverse event health consequences.

• Brand Name: MYOSURE ROD LENS HYSTEROSCOPE
• Type of Device: UTERINE HYSTEROSCOPE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 9603454
• MDR Text Key: 176867036
• Report Number: 1222780-2020-00014
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 40-250
• Device Catalogue Number: 40-250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention; Other