MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-09-29 for ULTRASONIC SURGICAL SYSTEM SONOSURG G-2 manufactured by Olympus Medical System Corporation.
[1375807]
The user facility reported that during a laparoscopic lysis of adhesion surgery, the distal tip broke off, and the sonosurg g2 generator reportedly did not provide an alarm. The separated portion of the device was recovered during the same procedure with graspers. The procedure was completed with another sonosurg probe. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8772220]
The device referenced in this report was not returned to olympus for evaluation. The user facility was contacted following the event to gather additional information, but could not identify which one of multiple generators at the facility had been used in the procedure. The exact cause of the reported phenomenon could not be conclusively determined at this time. If the subject device is returned for evaluation, a supplemental report will follow. This report is in reference of mfr report # 8010047-2010-00192. Olympus america inc. Is filing mdrs on behalf of (b)(4) and olympus medical systems corporation. (b)(4). This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00193 |
| MDR Report Key | 1853628 |
| Report Source | 06 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-09-02 |
| Date of Event | 2010-09-02 |
| Date Added to Maude | 2010-12-03 |
| 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 | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASONIC SURGICAL SYSTEM SONOSURG |
| Generic Name | ELECTROSURGICAL UNIT |
| Product Code | FTJ |
| Date Received | 2010-09-29 |
| Model Number | G-2 |
| Lot Number | NA |
| 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 SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-29 |