MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-06 for SINGLE USE ELECTROSURGICAL SNARE UNKNOWN manufactured by Olympus Medical Systems Corp..
[182470369]
The subject device was not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[182470370]
Olympus medical systems corp. (omsc) received a literature title "single-center implementation of endoscopic submucosal dissection (esd) in colorectum: low recurrence rate after intention-to-treat esd". The literature reported the result of 83 cases of the endoscopic submucosal dissection intention-to-treat (esd-itt) using olympus instruments (unspecified dual knife, unspecified hook knife, unspecified coagrasper forceps and monofil snares) between november, 2009 and june, 2016. In the 83 cases of the esd-itt, the eight patients developed complications. Six patients developed transmural microperforations. Five of them recovered by tightly clipping without clinical consequences. One patient had a small retroperitoneal perforation in the hepatic flexure was diagnosed and tightly clipped with delay. After 12 hours, however, the patient underwent right-sided hemicolectomy because of rising inflammatory parameters in the presence of retroperitoneal and mediastinal emphysema. All of six patients were discharged within 10 days after the esd-itt. And one patient developed delayed bleeding, but recovered without long-term morbidity. In addition, one patient developed anorectal stenosis, but cured with two sessions of balloon dilation. Further detailed information could not be obtained from the user facility at present. According to the number of patients and devices, omsc is submitting 32 medical device reports. This report is 26 of 32 reports for microperforation (2 of 6) at monofil snares.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01664 |
| MDR Report Key | 9796955 |
| Report Source | LITERATURE |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-06 |
| 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 | 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 | SINGLE USE ELECTROSURGICAL SNARE |
| Generic Name | ELECTROSURGICAL SNARE |
| Product Code | FDI |
| Date Received | 2020-03-06 |
| Model Number | UNKNOWN |
| Device Availability | N |
| 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 | 2020-03-06 |