MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-06-26 for SINGLE USE ROTATABLE CLIP FIXING DEVICE HX-201UR-135L NA manufactured by Olympus Medical Systems Corporation.
[4695598]
Olympus med systems corp (omsc) was informed that the clip could not be detached from the device after clipping tissue. The doctor tried to pull out the tube sheath several times but the clip could not be dislodged from the tissue. The nurse took pliers to prevent the tissue from tearing and attempted to cut the insertion portion of the device. When the nurse lifted the handle, the clip broke away from the device. The doctor replaced the subject device with another and completed the procedure. There was no report of patient injury regarding this report.
Patient Sequence No: 1, Text Type: D, B5
[11932434]
The subject product was returned to omsc for investigation. The investigation confirmed that the part which held on the clip was deformed and the clip detached from it. Tube joint tore from the tube sheath. In addition, there was handle damage and coil sheath bent near handle. The slider worked smoothly. Also, as the result of checking the mfg record of the same lot, nothing abnormal detected. Omsc therefore assumes that this event was attributed to the large angle of the bending section of the endoscope or the handle mishandling. 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 | 8010047-2014-00364 |
| MDR Report Key | 4003135 |
| Report Source | 01,08 |
| Date Received | 2014-06-26 |
| Date of Report | 2014-06-18 |
| Date of Event | 2014-05-27 |
| Date Mfgr Received | 2014-06-18 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-08-21 |
| 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 |
| Manufacturer Phone | 26425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE ROTATABLE CLIP FIXING DEVICE |
| Generic Name | CLIP FIXING DEVICE |
| Product Code | FZG |
| Date Received | 2014-06-26 |
| Returned To Mfg | 2014-06-10 |
| Model Number | HX-201UR-135L |
| Catalog Number | NA |
| Lot Number | K3604 |
| ID Number | NA |
| 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 | 2014-06-26 |