MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for CYSTOSCOPE SHEATH, 25FR. A20915A manufactured by Olympus Winter & Ibe Gmbh.
[118812840]
The device has not been returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. Despite multiple followup attempts by phone and in writing, no further information is available regarding the name of the procedure, the sequence of events, whether and how the procedure was completed, the patient? S current state, the role or performance of the separate forceps device in the event, or the make and model number of the broken stone crushing device. It has also not been confirmed if the forceps device is the same device as the stone crusher. The oem performed a review of the device history record and found no related anomalies at the time of manufacturing release. As preventive measures, the instruction document for the cystoscope sheath device specifies the olympus product that is compatible with the device and states that the device is for use with optical forceps and? Compatible telescope?. The instruction document also cautions that when withdrawing,? Make sure that the instrument stopcock is open and the jaws [of the optical forceps] are closed when withdrawing the instrument. Never withdraw the instrument with excessive force.? The instruction document also requires pre-procedure inspection and has instructions for the inspection.
Patient Sequence No: 1, Text Type: N, H10
[118812841]
One of 2. Olympus was informed that during an unknown procedure, the sheath bent while inside the patient, trapping and breaking a stone crusher. The procedure also involved a separate olympus optical forceps device. All device fragments were retrieved from the patient. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00496 |
| MDR Report Key | 7827827 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-08-02 |
| Date Added to Maude | 2018-08-29 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CYSTOSCOPE SHEATH, 25FR. |
| Generic Name | CYSTOSCOPE SHEATH, 25FR. |
| Product Code | GCP |
| Date Received | 2018-08-29 |
| Model Number | A20915A |
| Catalog Number | A20915A |
| Lot Number | 183W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |