MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION CURETTE

Model Number CC-4CR-1

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that during bronchus endoscopy, the distal joint section fell off in the bronchus.The doctor retrieved the fragment with grasping forceps.The doctor completed the procedure with another device.The patient didn't accept postoperative complications.And the patient left the hospital as scheduled.There was no patient injury regarding this report.

Manufacturer Narrative

The device was returned to omsc for investigation.The investigation confirmed that both the coil sheath and the wire fractured in about 35 mm from the distal end.The wire bended in the distal side, and the fracture surface of the coil showed that the load was applied from the inside of the coil towards the outside.It was restricted for the distal tip of the subject device to bend because fibrous foreign objects entangled around the distal tip.As the result of checking the manufacturing record of the same lot, nothing abnormal detected.Based on the confirmation of the subject device, olympus concluded that this event occurred due to the fracture of the coil sheath and the wire.The cause of the fracture was presumed as provided below.First, an excessive bending force was applied on the subject device during endoscopy, and the coil sheath and the wire buckled.Next, the coil sheath fractured because the doctor compulsorily spun the device while the fibrous foreign bodies adhered to the distal end.Then, the wire was ruptured because the doctor pulled the slider compulsorily.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: CURETTE
• Type of Device: CURETTE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507
• MDR Report Key: 4645784
• MDR Text Key: 5757468
• Report Number: 8010047-2015-00211
• Device Sequence Number: 1
• Product Code: FZS
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CC-4CR-1
• Device Lot Number: K2216-5732
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1