MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE FOR ESOPHAGUS

Model Number MH-908

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2015

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has been returned to keymed ltd.For evaluation.The evaluation found that the distal end cap and the distal end cap ring ("ring") were detached from the distal end, and the reported phenomenon thus was confirmed.Evidence of a chemical attack was found on the surface of the insertion tube.The adhesive glue and binding used to secure the ring and the distal end cap to the distal end of the instrument were found to be missing.There were some scratches on the surface of the distal end cap.The two locating stopper pins were intact with no evidence of damage.The manufacturing record of the subject device was reviewed with no abnormality possibly associated with the reported phenomenon.The instrument was last received by olympus service on (b)(4) 2014 and a minor repair to replace the distal cap and the bending rubber.Based on the evaluation, the exact cause of the parts drop-off could not be conclusively determined at this time, but a possible mechanism of the phenomenon was supposed that the adhesive to secure the ring and the distal end cap was deteriorated by chemical attack such as detergent solution and then external force was applied to the distal end cap.Furthermore, position gap between the distal cap and the ultrasonic unit may cause ultrasonic image irregularity.

Event Description

The ultrasonic image irregularity occurred and the device was removed from the patient.Then the procedure was abandoned.The subject device was checked immediately after removal from the patient and the facility observed that the distal cap was loose and came off from the instrument and fell off into the nurse's hand.The procedure was aborted, but there was no patient injury reported.

• Brand Name: ULTRASONIC PROBE FOR ESOPHAGUS
• Type of Device: ULTRASONIC PROBE
• 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: 5389801
• MDR Text Key: 36806874
• Report Number: 8010047-2016-00158
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K#: K952892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MH-908
• Device Catalogue Number: MH-908
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2003
• 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