MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-06 for GF-UM20 27014 manufactured by Olympus Optical Co. Ltd..
[21582914]
During an exploratory ultrasound procedure in which the dr. Was attempting to evaluate a duodenal adenoma with an ultrasonic gastrofiberscope, pt sustained a perforation in the duodenum. The hosp. Nurse reported that the pt's duodenum was weak and friable prior to the exploratory exam. Pt was taken to surgery for repair of the perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429304-1997-00009 |
| MDR Report Key | 74707 |
| Date Received | 1997-03-06 |
| Date of Report | 1997-02-24 |
| Date of Event | 1997-01-31 |
| Date Facility Aware | 1997-01-31 |
| Report Date | 1997-02-24 |
| Date Reported to FDA | 1997-02-24 |
| Date Reported to Mfgr | 1997-02-24 |
| Date Added to Maude | 1997-03-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GF-UM20 |
| Generic Name | GF-UM20 GASTROINTESTINAL FIBERSCOPE FOR US |
| Product Code | GDB |
| Date Received | 1997-03-06 |
| Model Number | GF-UM20 |
| Catalog Number | 27014 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 74512 |
| Manufacturer | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Address | 22-2 NISHI SHINJUKU 1-CHOME SHINJUKU SAN-E1 BLDG. SHINJUKU-KU, TOKYO JA |
| 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 | 1997-03-06 |