MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION PROBE

Model Number MAJ-985

Device Problem Material Fragmentation (1261)

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

Event Date 03/26/2012

Event Type  malfunction  

Manufacturer Narrative

The subject devices were returned to omsc for investigation.Returned devices were one maj-984 and two maj-985s.There was no report which maj-985 was related to the phenomenon.There were scratches at the tips and the middle positions of all subject devices.We consider that these scratches at the middle were likely to be caused by the scope having touched to the probe activating output.The tiny shards of metal were caused when the scope touched to the probe activating output.It might have related to improper user handling.Almost all of the tiny shards of metal will be collected by irrigation fluid flow.Also, olympus states the appropriate handling of the maj-984, maj-985 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 8010047-2017-10041, 8010047-2017-10042.

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 customer reported that on 2 recent occasions of nephron-lithotripsy using lus-2 along with the maj-984 and maj-895 probes, they have experienced very tiny shards of metal coming off the probes into the patient.The lus-2 & maj-984 probes are being used in conjunction with a wolf short nephroscope with 4mm channel.There was no patient injury reported.This mdr is to account for one case using the subject maj-985 (second one).

• 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: yutaka yanagawa ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426423078
• MDR Report Key: 6269176
• MDR Text Key: 65458460
• Report Number: 8010047-2017-10040
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2012
• Date Manufacturer Received: 04/10/2012
• 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