MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS; HYSTEROSCOPE (AND ACCESSORIES)

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2022

Event Type  malfunction  

Event Description

As soon as the scope was introduced into the bladder of the patient, the tip of the 26 fr resection sheath was visualized as simply falling off into the bladder.Doctor used alligator grasper to remove the tip from the bladder without injury or incident.

• Brand Name: OLYMPUS
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 15417061
• MDR Text Key: 299854691
• Report Number: 15417061
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Date Report to Manufacturer: 09/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA