MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-21 for SINGLE USE RETRIEVAL BASKET V FG-V435P manufactured by Olympus Medical Systems Corp..
[142631495]
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. The manufacturing record was reviewed and found no irregularities. Based on the past similar cases, it was known that subject device was incarcerated due to the state of the patient or calculus, or due to the basket deformation by repeated use. The above device handling has warned in the instruction manual as follows: do not use this instrument for a calculus that is assumed impossible to be retrieved by this instrument in preoperative diagnosis, intraoperative contrast enhancing or after papillotomy/papillary dilation. Do not use this instrument when it is inevitable to grasp many calculus at a time. The basket with calculus engaged may not be removed from the body. Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case this instrument with calculus engaged may not be removed from the body, or in case the calculus cannot be crushed even the lithotriptor bml-110a-1 is used in combination. This instrument will deform and/or deteriorate by performing calculus retrieval. Repetition of calculus retrieval will extend the effect. By such deformation and/or deterioration, calculus may not be retrieved and/or the basket with calculus engaged may not be removed from the body. If calculus retrieval needs to be repeated in a single case, make sure to check the action and the appearance each time that no abnormality is detected (e. G, basket wire cut or worn, tube sheath bent etc. ). Stop use when any abnormality is detected.
Patient Sequence No: 1, Text Type: N, H10
[142631496]
During an endoscopic retrograde cholangiopancreatography, the subject device was used. In the procedure, the subject device was incarcerated. The incarceration was managed to use an emergency lithotriptor, but the user could not release the incarceration. The user released the incarceration and completed the intended procedure with another device. There was no patient injury reported. This is the report regarding the incarceration of bile duct stones.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-01744 |
| MDR Report Key | 8534350 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-21 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-04-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE RETRIEVAL BASKET V |
| Generic Name | SINGLE USE RETRIEVAL BASKET |
| Product Code | LQR |
| Date Received | 2019-04-21 |
| Model Number | FG-V435P |
| Lot Number | 8XK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-21 |