MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE; CYSTO-NEPHRO VIDEOSCOPE

Model Number UM-S20-17S

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.The evaluation revealed the presence of red-colored foreign substance inside the distal end of the sheath of the subject device.The distal end of the sheath was damaged, and ultrasonic medium was leaking.The damaged part was observed to be crumpled.The cause of the event is surmised that the distal end of the sheath was damaged for unspecified reason, and the patient's bodily fluid or blood intruded from the damaged part.The exact cause could not be determined at this time, but our experience shows that the distal end of the sheath may be damaged when removing a probe stopper after the subject device is used in combination with a guide sheath and probe stopper.The manufacturing record of the subject device was reviewed without irregularity.If additional information becomes available at a later time, this report will be supplemented.

Event Description

The user facility became aware that there was blood remaining inside the sheath after the subject device was cleaned and disinfected using an automatic endoscope reprocessor.The user facility again cleaned the subject device, but could not remove the blood.There was no patient injury reported.

• Brand Name: ULTRASONIC PROBE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5462358
• MDR Text Key: 39088287
• Report Number: 8010047-2016-00367
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K#: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UM-S20-17S
• Device Catalogue Number: UM-S20-17S
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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