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 Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the device scale was off and not reading the top scale.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned sample met specification as received.The visual inspection found there were no indications of transport damage, one gaiter was chipped and the wheels were scratched.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.All replacement parts were installed, the device was fully tested and is functioning per specifications.Calibration and testing were conducted.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; salzufer 8; berlin 10587
• Manufacturer (Section G): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9121504
• MDR Text Key: 160126348
• Report Number: 1717344-2019-01216
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: 72205001
• Device Catalogue Number: 72205001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2020
• 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: Unknown
• Patient Sequence Number: 1