MAUDE Adverse Event Report: HOLOGIC, MARLBORUGH MA MYOSURE XL ROD LENS HYSTEROSCOPE

Catalog Number 50-250XL

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

An adverse event did not occur.A near adverse event occured.No patient injury reported and there was no malfunction.No serious injury.A near adverse event occured.No patient injury reported and there was no malfunction.Investigation from oem: (b)(4) was last shipped as a new xl scope on 01/18/2013 and has not been returned to the oem for repair or evaluation since that time.Based on the information on the product experience report (per), (b)(4) is being "sent to local company for assessment/cleaning." there is no statement if the hologic ifu is being followed in order to properly clean the device.If scopes are cleaned to the manufacturer's instructions, there should be no "debris" present in the working channel of these scopes.Scopes must be cleaned correctly after every procedure and to the ifu.The field customer continues to submit comments/complaints regarding (b)(4) but refuses to return the scope to the oem for evaluation and repair.No other information can be supplied without the scope being made available for analysis.(b)(4).

Event Description

Limited information was reported by the user facility on 12/02/2016.The user facility reported the myosure xl hysteroscope had "fleshy particles lodged inside" the working channel of the hysteroscope.There was no patient injury.Customer stated that " fleshy particles lodged inside" could potentially a poses a general infection control risk.No additional information forthcoming.

Manufacturer Narrative

Scope evaluation sn#(b)(4): clean, no debris.Sn#(b)(4): clean, no debris.Sn#(b)(4): distal tip deposits broken optics, scope unusable due to broken optics.Sn#(b)(4): no debris, some discoloration.(b)(4).

• Brand Name: MYOSURE XL ROD LENS HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE
• 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: 6212163
• MDR Text Key: 63479013
• Report Number: 1222780-2016-00324
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122563
• 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: 12/02/2016

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: Physician
• Device Catalogue Number: 50-250XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: MYOSURE CONTROL UNIT-SERIAL # UNK
• Patient Outcome(s): Other