MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for CYSTOURETHROSCOPE SHEATHS 23FR E123-O manufactured by Gyrus Acmi Inc,.
[24679792]
The device referenced in this report was returned to olympus for evaluation. The evaluation could not confirm the reported event. A visual inspection of the device found no scrapes, dents or other damage that shows metal or pieces of the device fell off the unit. The exact cause of the reported complaint could not be conclusively determined. Cross reference: 2951238-2015-00395, 2951238-2015-00400.
Patient Sequence No: 1, Text Type: N, H10
[24679793]
Olympus was informed that during a diagnostic total laparoscopic hysterectomy procedure, metal flakes from several different components on the device were falling off into the patient's bladder. The surgeon used a grasper and successfully retrieved all the device fragments. The intended procedure was completed with the same device. There was no patient injury reported. The patient was discharged home with no complications. Olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the device was inspected and tested prior to the procedure with no anomalies found. This is two of three reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2015-00399 |
| MDR Report Key | 5021504 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-08-06 |
| Date Mfgr Received | 2015-08-06 |
| Date Added to Maude | 2015-08-21 |
| 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 | 3 |
| Manufacturer Contact | MRS. NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CYSTOURETHROSCOPE SHEATHS 23FR |
| Generic Name | SHEATH WITH STANDARD OBTURATOR |
| Product Code | FEC |
| Date Received | 2015-08-21 |
| Returned To Mfg | 2015-08-12 |
| Model Number | E123-O |
| Catalog Number | E123-O |
| Lot Number | GP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI INC, |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 018822104 US 018822104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |