MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-12-29 for OLYMPUS MH-969 NA manufactured by Olympus Optical Co. Ltd.
[296932]
The hosp reported their cord separated from the end of the connection during a procedure. The procedure was complete with another cord. There was no allegation of harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2003-10114 |
| MDR Report Key | 508617 |
| Report Source | 05,07 |
| Date Received | 2003-12-29 |
| Date of Report | 2003-12-03 |
| Date Mfgr Received | 2003-12-03 |
| Date Added to Maude | 2004-01-30 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARK GAYLE |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355114 |
| Manufacturer G1 | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1 CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | ACTIVE CORD |
| Product Code | FFZ |
| Date Received | 2003-12-29 |
| Returned To Mfg | 2003-12-10 |
| Model Number | MH-969 |
| Catalog Number | NA |
| Lot Number | 34K |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 497564 |
| Manufacturer | OLYMPUS OPTICAL CO. LTD |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1 CHOME TOKYO JA 163-91 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | ACTIVE CORD |
| Baseline Model No | MH-969 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-29 |