MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-29 for LOOP CUTTER FS-5Q-1 manufactured by Olympus Medical Systems Corp..
[30246116]
The insertion portion of the subject device was returned to olympus medical systems corp. (omsc) for investigation. The investigation confirmed that the handle was severed. The loop was caught by the cutter and the loop hanger, and was crushed. Omsc measured the dimensions of the cutter and the loop hunger. As a result, they satisfy the product standards. As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected. Based on the investigation of the subject device, omsc concluded that the loop was caught in the loop cutter, because the doctor pulled the slider without positioning the loop vertically to the loop hunger. The instruction manual of the subject device warns; do not try to cut the loop that is not positioned on both edges of the loop hanger as plumb as possible for the blade. It may make cutting the loop impossible, or result in the loop getting caught in the distal end of the instrument, which could make it difficult or impossible to remove from the patient. In this case, use pliers to cut the insertion portion of the instrument where it extends from the biopsy valve of the endoscope. Remove the endoscope from the body, then reinsert the endoscope and cut the loop with a spare loop cutter. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[30246117]
It was informed that the doctor attempted to cut the loop with the subject device during a colorectal polypectomy. Then the loop stuck in the subject device, and the subject device could not come off the loop. The doctor severed the handle of the subject device, and withdrew the only scope from the patient. After that, the doctor inserted the scope again, cut the loop with another device, and completed the intended procedure. At the same time, the doctor could withdraw the remaining parts of the subject device, which couldn't come off the loop, from the patient. The patient left the hospital on the same day. There was no other patient injury regarding this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2015-01049 |
| MDR Report Key | 5187062 |
| Date Received | 2015-10-29 |
| Date of Report | 2015-10-14 |
| Date of Event | 2015-10-14 |
| Date Mfgr Received | 2015-10-15 |
| Date Added to Maude | 2015-10-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LOOP CUTTER |
| Generic Name | LOOP CUTTER |
| Product Code | JYA |
| Date Received | 2015-10-29 |
| Returned To Mfg | 2015-10-15 |
| Model Number | FS-5Q-1 |
| Lot Number | 0YK |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-29 |