MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS RESECTION SHEATH

Model Number A22040A

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/26/2014

Event Type  Injury  

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the ceramic tip of the device broke off and fell inside the patient's bladder.The patient was then taken to the operating room and for an open surgery in an attempt to retrieve the ceramic tip.The ceramic tip was successfully retrieved from the patient, and the patient's current condition is stable.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information is available at a later time or if the device is returned for evaluation, this report will be supplemented.

• Brand Name: OLYMPUS RESECTION SHEATH
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131-1700 ; 4089355002
• MDR Report Key: 4337715
• MDR Text Key: 5172814
• Report Number: 2951238-2014-00623
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/12/2014
• 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