MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-04 for LOOP CUTTER FS-5L-1 NA manufactured by Olympus Medical Systems Corporation.
[20326155]
Olympus medical systems corp (omsc) was informed that the doctor attempted to place an esophageal stent manufactured by (b)(4) to the patient and cut its band using the subject device. Then the band was stuck in the cutter and the doctor could not temporarily withdraw the device from the patient. The doctor burned off the band with a laser and withdrew the device from the patient. The procedure was completed with another device. There was no report of patient injury regarding this report.
Patient Sequence No: 1, Text Type: D, B5
[20573944]
The subject device was returned to omsc for investigation, the investigation confirmed that the band was stuck in the cutter part. When removing it from cutter part, the cutter opened and closed smoothly. The cutter was not deformed and as the result of checking the manufacturing record of the same lot, nothing abnormal was detected. Thus, omsc considers that cutting the band of the stent caused this event. 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 | 8010047-2014-00169 |
| MDR Report Key | 3931343 |
| Report Source | 05,06 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-03-28 |
| Date of Event | 2014-03-28 |
| Date Mfgr Received | 2014-03-28 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2014-07-24 |
| 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 | 0 |
| 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 | LOOP CUTTER |
| Generic Name | LOOP CUTTER |
| Product Code | HIN |
| Date Received | 2014-04-04 |
| Returned To Mfg | 2014-04-07 |
| Model Number | FS-5L-1 |
| Catalog Number | NA |
| Lot Number | K2Y30-0154 |
| 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 | 2014-04-04 |