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

Model Number A22040A

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device has been returned for evaluation.The customer¿s complaint of the device tip broke off was confirmed.The service technician observed the beak broken off and the device damaged.The cause could not be determined.Based on similar reported complaints, the most likely cause of the reported phenomenon can be attributed to user handling or technique.No further information was reported.

Event Description

The customer reported to olympus that during a procedure the tip broke off and fell inside the patient.The broken piece was successfully retrieved.The physician visually inspected the bladder after the tip was retrieved and determined the entire tip was retrieved.There was no patient injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr.The original equipment manufacturer (oem), performed a device history record review and no abnormalities were noted.No device was returned to oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause is likely attribute to thermo-mechanical fatigue.Another possible cause is mechanical overload, impact, accidental dropping, etc.As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.The dent on the tube and the faded marking can most likely be attributed to wear and tear.An investigation is ongoing with the oem regarding the insulation insert long term stability.Olympus will continue to monitor the field performance of this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10361849
• MDR Text Key: 224676283
• Report Number: 9610773-2020-00179
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 16ZW-0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1