MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22040A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the ceramic beak was missing from the rectoscope sheath noticed upon reprocessing the device.It was noted that the inner sheath of ceramic beak was broken at the end.Reportedly, the ceramic beak broke off during the rigid cystoscopy procedure.It is unknown if medical intervention was undertaken to retrieve the device, but diagnostic intervention was undertaken, and an x ray and ct scan was performed, and no device beak was located.It was reported that procedural delay and extended patient hospitalization due to the event are unknown.The procedure was completed with the same set of equipment.No reports patient harm.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18699509
• MDR Text Key: 335294306
• Report Number: 9610773-2024-00444
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Lot Number: 20Y17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention