MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-19 for LOOP CUTTER FS-5L-1 manufactured by Olympus Medical Systems Corporation.
[5422275]
During an esophageal achalasia's postoperative inspection, the doctor tried to remove a suture thread using the subject device since he judged the suture thread used at the time of the operation could cause passage disorder. The suture thread was closely fixed to the mucous membrane, and the subject device got entangled. The scope was removed from the patient body after cutting of a part of the handle using pliers. After that the scope was inserted again, and the suture thread was cut using the spare (b)(4) device. Bleeding occurred in this occasion.
Patient Sequence No: 1, Text Type: D, B5
[12781606]
The subject device was returned to olympus for investigation. The investigation confirmed that a suture thread was caught between a loop hanger and cutter and the suture thread could not be detached from the subject device. The purpose of the subject device is cutting a loop. The cause of this event is a user's attempt of cutting a suture thread, which is different from the original purpose. It is supposed that the suture thread was thin and easy to be caught between the loop hanger and cutter. The device instruction manual has indicated that this device can't be removed from a patient body if this device is used for different purposes. 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 | 8010047-2015-00040 |
| MDR Report Key | 4456762 |
| Report Source | 05,06 |
| Date Received | 2015-01-19 |
| Date of Report | 2014-12-25 |
| Date of Event | 2014-12-25 |
| Date Mfgr Received | 2014-12-25 |
| Device Manufacturer Date | 1998-10-01 |
| Date Added to Maude | 2015-02-13 |
| 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 | LOOP CUTTER |
| Generic Name | LOOP CUTTER |
| Product Code | HIN |
| Date Received | 2015-01-19 |
| Returned To Mfg | 2015-01-14 |
| Model Number | FS-5L-1 |
| Lot Number | K8X23 |
| 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 | 2015-01-19 |