MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-05-27 for OLYMPUS GF-UM20 NA manufactured by Olympus Optical Co. Ltd..
[382584]
The hosp reported during a procedure, the physician noted a change in the picture's quality and removed the endoscope. After doing so, the physician noticed the tip of the device was missing. The physician went back into the pt with another endoscope and retrieved the plastic tip from the pt's stomach. With a retrieval net. The hosp reported that sometime during the course of the procedure, the pt sustained a tear to the gastroesophageal junction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2005-00054 |
| MDR Report Key | 608304 |
| Report Source | 07 |
| Date Received | 2005-05-27 |
| Date of Report | 2005-04-28 |
| Date Added to Maude | 2005-06-01 |
| 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 | 0 |
| Manufacturer Contact | MARK GAYLE |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355059 |
| Manufacturer G1 | OLYMPUS OPTICAL CO. LTD |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU, 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 | ULTRASONIC GASTROFIBERSCOPE |
| Product Code | GCQ |
| Date Received | 2005-05-27 |
| Returned To Mfg | 2005-05-03 |
| Model Number | GF-UM20 |
| Catalog Number | NA |
| Lot Number | NA |
| 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 | 598100 |
| Manufacturer | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU TOKYO JA 163-91 |
| Baseline Brand Name | GF-UM20 |
| Baseline Generic Name | GASTROINTESTINAL FIBERSCOPE FOR US |
| Baseline Model No | GF-UM20 |
| Baseline Catalog No | 27014 |
| Baseline ID | SERIAL #1600825 |
| Baseline Device Family | ULTRASOUND SCOPES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K926514 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-05-27 |