MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SUCTION VALVE

Model Number MD-493

Device Problems Cut In Material (2454); Device Contamination With Biological Material (2908); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.According to the evaluation, though there were two separate cuts found in the o-ring on the distal end side, abnormal conditions and foreign materials were not found in other o-rings and the external appearance.There were no foreign materials observed.Olympus investigated the user facility and found that the user facility did not perform pre-cleaning.Based upon the evaluation and investigation, this event might be caused by not performing pre-cleaning.Furthermore, it is considered that the cuts of the o-ring were a possible cause because adequate reprocessing could not be performed if there was a cut in an o-ring.Please cross-reference to 8010047-2016-00443.

Event Description

Bacterial culture examination was performed on 3 units of lf-tp (tracheal intubation fiberscope) and 3 units of the subject product, which were stored in the user facility, and pseudomonas aeruginosa was detected from the subject device and another device.Bacteria were not detected from 3 units of lf-tp.There was no patient injury reported.

Manufacturer Narrative

This supplement report is submitted to report additional information.As a result of observing a spring of the subject device with the scanning electron microscope, it was confirmed that foreign materials adhered.As analyzing the foreign materials, protein was detected.Foreign materials adhered to 3 units in total as follows: 2 units including the subject device in which pseudomonas aeruginosa was detected, 1 unit in which pseudomonas aeruginosa was not detected.Either of the ingredients was confirmed to be protein, but the relation with pseudomonas aeruginosa detected from the subject device is not unknown.

• Brand Name: SUCTION VALVE
• Type of Device: SUCTION VALVE
• 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: 5537164
• MDR Text Key: 41542666
• Report Number: 8010047-2016-00442
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K#: K002231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MD-493
• Device Catalogue Number: MD-493
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• 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