MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72205001

Device Problem Incorrect Measurement (1383)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during servicing at the facility, the scale test was not within the normal limits.There was no patient involvement.

Manufacturer Narrative

This event has been reassessed and found not to be a reportable event and is not associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; alte pststrabe, 11 - 96337; ludwigsstadt 96337
• Manufacturer (Section G): W.O.M WORLD OF MEDICINE GMBH; alte pststrabe, 11 - 96337; ludwigsstadt 96337
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9673403
• MDR Text Key: 178262355
• Report Number: 1717344-2020-00118
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K180496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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: Health Professional
• Device Model Number: 72205001
• Device Catalogue Number: 72205001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 02/11/2020
• 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