MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-27 for CURETTE CC-4CR-1 manufactured by Olympus Medical Systems Corporation.
[5757468]
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.
Patient Sequence No: 1, Text Type: D, B5
[13097235]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2015-00211 |
| MDR Report Key | 4645784 |
| Report Source | 05,06 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-03 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2015-03-03 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2015-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURETTE |
| Generic Name | CURETTE |
| Product Code | FZS |
| Date Received | 2015-03-27 |
| Returned To Mfg | 2015-03-17 |
| Model Number | CC-4CR-1 |
| Lot Number | K2216-5732 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-27 |