MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS; WATER-RESISTANT CAP

Model Number MH-553

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Scarring (2061); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.The manufacturing history was not reviewed, because the lot number of the subject device is unknown.As result of the reproduction examination, the gap of the groove on the venting connector of the subject device was reproduced by pulling out forcibly not turning the subject device until it completely stops at the end corner of the connector cap of the connected device ((b)(4)), when the leak test air tube (maj-821) /leakage tester (mb-155) was disconnected from the subject device.The instructions of leakage tester (mb-155) and leak test air tube (maj-821) states the proper disconnection procedure of the leak test air tube (maj-821)/ leakage tester (mb-155) from the subject device.User's handling could not be ruled out as a contributory factor to the gap of the groove on the venting connector of the subject device.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus was informed that during connecting the subject device to the leak test air tube((b)(4)), a health professional at the user facility was not able to connect the tube to the subject device because the groove on the venting connector of the subject device is not properly aligned.The health professional stabbed herself in the finger and got hurt when the health professional attempted to correct the gap of the groove on the venting connector using a driver.Since health professional did not give treatment to the wound on her finger, the wound festered.At the time of report of this event, the wound of the health professional had been healed.

• Brand Name: OLYMPUS
• Type of Device: WATER-RESISTANT CAP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachiouji-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: 5222101
• MDR Text Key: 31181561
• Report Number: 8010047-2015-01068
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MH-553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: No
• 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