MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-14 for LOOP CUTTER FS-5U-1 manufactured by Olympus Medical Systems Corp..
[187257634]
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10
[187257635]
The national competent authority (b)(6) informed olympus medical systems corp. (omsc) the following event on december 23, 2019. During an endoscopy to cut a wire mersuture intra-gastric in the cardiac area, the subject device was used. The loop cutter was closed over the wire to cut it. After this first closing, the loop cutter did not cut the wire and moreover remained stuck on the wire, making it impossible to open the scissor. The loop cutter was finally broken and left in the patient, the endoscope was removed. Another pair of forceps was inserted into the endoscope, which also failed to cut the wire. A surgeon was called and the conversion was considered. The intervention time was more than 60 minutes. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-00889 |
| MDR Report Key | 9585301 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-01-14 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-06-24 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-01-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 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 | 3 |
| Brand Name | LOOP CUTTER |
| Generic Name | LOOP CUTTER |
| Product Code | PTS |
| Date Received | 2020-01-14 |
| Model Number | FS-5U-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |