MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP OLYMPUS; URETEROSCOPE SHEATH DILATOR

Model Number ST-U1

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2010

Event Type  Injury  

Manufacturer Narrative

Since the lot number of the subject device is unknown, it is not possible to review the manufacturing history of the device.That part of the subject device (the fell-off fragment into the patient) was returned to olympus for evaluation.As a result of composition analysis of the fragment, it was found that the subject device broke from brittle fracture caused by hydrolytic degradation.The facility used a sterrad sterilizer for sterilization of the subject device.In addition, it was found that the subject device was delivered to the facility on april 1, 2008, and has been used for more than one and half years.As stated above, the reported phenomenon of the subject device was caused by chemical damage due to sterilization method (sterilization with a sterrad sterilizer) which is not instructed in the ifu.

Event Description

Olympus medical systems corp.(omsc) performed a mdr retrospective review and found that this report was required.The physician attempted to insert urf-p5 into the patient through the subject sheath dilator, but failed.The patient underwent ct scan.The physician found that the sheath dilator broke and fell off inside the patient.The physician performed open surgery and ureteral incision.The fell-off fragment was retrieved.The patient was reportedly doing fine.

• Brand Name: OLYMPUS
• Type of Device: URETEROSCOPE SHEATH DILATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP; 2951; ishikawa; hachiouji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachiouji-chi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 6278796
• MDR Text Key: 65776331
• Report Number: 8010047-2017-10077
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/26/2017

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: ST-U1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2010
• Initial Date FDA Received: 01/26/2017
• 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: Reuse
• Patient Sequence Number: 1