MAUDE Adverse Event Report: UNKNOWN UNKNOWN

Model Number UNKNOWN

Device Problem Contamination (1120)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to omsc for evaluation.Because the model name and serial number of this device are unknown, omsc couldn¿t confirm the manufacturing history of this device.Also, the user facility has not complained of a malfunction with this device.Furthermore, olympus staff visited the user facility and confirmed the operation of the automated endoscope reprocessor, no irregularity was found.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that two unknown procedures using the subject device were performed on two patients and the intended procedure was completed without problems.But, at a later date, two patients complained of abdominal pain, and they visited another hospital.The patients outcome are unknown.This device had been reprocessed using an olympus automated endoscope reprocessor model oer-3 (not available in the usa) with peracetic acid after manual cleaning.This is 1 of 2 reports.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): UNKNOWN
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7124820
• MDR Text Key: 95231209
• Report Number: 8010047-2017-02006
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• 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): Other