MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for OSCILLATING ULTRASONIC PROBE 27093LL-S manufactured by Karl Storz Se & Co. Kg.
[128270356]
The device has not yet been returned for evaluation; however, our sales representative viewed the device and also provided a picture, which shows three pieces were broken off of the oscillating probe tip. The hospital confirmed that the broken pieces were retrieved and there was no harm to patient. In addition, we learned from the hospital that the kidney stone was very hard and that after the surgeon had been working on it for some time using this probe, the ultrasonic calcuson unit displayed a warning light; he continued using the probe and the tip eventually broke. It is possible the warning light was the transducer fault indicator - resonance warning, which can indicate either a damaged probe or transducer. A possible root cause of this type of breakage is overheating and/or mechanical overload. Both are user related issues and are addressed in our ifu.
Patient Sequence No: 1, Text Type: N, H10
[128270357]
Allegedly, during a percutaneous nephrolitomy procedure, three pieces of tip of the ultrasonic probe broke off into the patient. The broken pieces were retrieved and procedure was completed using a different probe. Hospital confirmed there was no injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00091 |
| MDR Report Key | 8096620 |
| Date Received | 2018-11-21 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2018-11-21 |
| 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. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSCILLATING ULTRASONIC PROBE |
| Generic Name | OSCILLATING ULTRASONIC PROBE |
| Product Code | FEO |
| Date Received | 2018-11-21 |
| Model Number | 27093LL-S |
| Catalog Number | 27093LL-S |
| Lot Number | ST01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-21 |