MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-04-08 for HD AUTOCLAVABLE CAMERA HEAD CH-S190-XZ-E NA manufactured by Olympus Medical Systems Corporation.
[5688771]
Olympus was informed that during laparoscopic tubal ligation procedure, the facility had connected the ch-s190-xz-e with combination equipment otv-s190 and clv-s190 after the patient had been anesthetized. But the lcd monitor had displayed error code b30 and had not shown an endoscopic image. Then the facility had cleaned connectors of the ch-s190-xz-e before having connected the device with the combination equipment again. However, the lcd monitor had still shown the same error code. The facility had replaced the device for another similar device and the procedure had been accomplished. There was no report of the patient's injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
[13218114]
The referenced device was returned to olympus medical systems corporation (omsc) for evaluation. Osmc evaluated the device and found that the phenomenon was reappeared to connect the device with another video system center otv-s190. There was no abnormality of water tightness of the device. But electrical continuity was unstable because of breaking wire partly. Consequently, otv-s190 could not detect connection with the device properly. Olympus attributed this phenomenon to inappropriate handling of the device by the user. The ch-s190-xz-e instruction manual states the notice for the handling of the device. Also, osmc checked the manufacture history of the subject device, there was no irregularity found. There were no further details provided. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2015-00243 |
| MDR Report Key | 4681869 |
| Report Source | 01,05,07 |
| Date Received | 2015-04-08 |
| Date of Report | 2015-10-03 |
| Date of Event | 2015-10-03 |
| Date Mfgr Received | 2015-03-10 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-04-13 |
| 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 | SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 26425177 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HD AUTOCLAVABLE CAMERA HEAD |
| Generic Name | CAMERA HEAD |
| Product Code | KQM |
| Date Received | 2015-04-08 |
| Returned To Mfg | 2015-03-18 |
| Model Number | CH-S190-XZ-E |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-08 |