MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION AUTOCLAVABLE TRANSDUCER "MAJ-1215", FOR LUS-2; AUTOCLAVABLE TRANSDUCER FOR LUS-2

Model Number MAJ-1215

Device Problems Break (1069); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

Olympus was informed that during an unspecified procedure pieces of metal from the probe attachment broke off and fell into the patient.The device fragments were removed from the patient with a grasper and irrigation.An x-ray was performed to confirm all debris was removed.There was a short delay in the procedure and no patient bleeding was reported.The physician attempted to attach two different probes to the same hand-piece and neither probe would securely attach to the device which caused the suction not to work.There was no patient injury reported.Olympus followed up with user facility to obtain additional information regarding the reported event and was informed that the device was inspected prior to the procedure and no anomalies were found.

Manufacturer Narrative

The referenced device in this report was returned to olympus for evaluation.The evaluation confirmed that the probe attachment was broken.The device was determined to be unserviceable and was discarded.This type of damage is most likely related to the operator's technique the instruction manual warns users "when connecting the hand pieces, do not apply excessive force to the hand piece cord.Doing so may cause equipment damage.If the ultrasonic output error indicator lights and all of the ultrasonic output level indicators, all of the suction level indicators, the output indication lamp and the suction indication lamp blinks, this means that lus-2 is not working properly; stable output cannot be supplied.".

• Brand Name: AUTOCLAVABLE TRANSDUCER "MAJ-1215", FOR LUS-2
• Type of Device: AUTOCLAVABLE TRANSDUCER FOR LUS-2
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4921728
• MDR Text Key: 6008583
• Report Number: 2951238-2015-00311
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K873367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2015

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: Health Professional
• Device Model Number: MAJ-1215
• Device Catalogue Number: MAJ-1215
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2007
• 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
• Treatment: MAJ-985 PROBE(X2) LOT# UNK