MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION PROBE

Model Number MAJ-984

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2011

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to okm ((b)(4)) for investigation.Okm investigated the subject device and found that there was friction mark observed on the subject device and on another maj-984 used during the procedure.It was reported that the facility used a non-olympus nephroscope with the subject device.According to the pictures from okm, it was found that the non-olympus nephroscope was bent a little.From the fact that the nephroscope was bent and its channel was also bent, the subject maj-984 might have activated the ultrasonic output contacting to the channel of the nephroscope and the subject maj-984 might have fractured by the friction at the contact point.The physician continued the procedure for 1 hour in the above condition, and might have been burned from the high temperature irrigating fluid due to the friction heat at the contact point.Also, olympus states the appropriate handling of the maj-984 and the counter-measures against the irregularity in the instruction manual.There were no further details provided.If significant additional information is received, this report will be supplemented.Cross reference mfr.Report number 8010047-2017-10039.

Event Description

Olympus medical systems corporation (omsc) performed a mdr retrospective review and omsc found that this report is required.Omsc was informed of the following; a physician performed a lithotripsy of a large staghorn stone with a lus-2, a non-olympus nephroscope and the subject maj-984.After approximately 1 hour into the procedure, the subject maj-984 fractured in the channel of the nephroscope.The physician withdrew the nephroscope and the subject device was retrieved.The subject maj-984 did not fall into the patient and there was no patient injury.The physician's hand was burnt when it contacted the irrigating fluid which was very hot.The physician completed the procedure using another maj-984.This mdr is to account for the subject maj-984's fracture.

• Brand Name: PROBE
• Type of Device: PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 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 ; 426425177
• MDR Report Key: 6265542
• MDR Text Key: 65676114
• Report Number: 8010047-2017-10038
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K873367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-984
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2011
• 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