MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-06 for ULTRASONIC PROBE 27093LL manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[30572091]
We suspect the stone was extremely hard, which may have contributed to the damage to the probe tip. The product is being sent to the manufacturer for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[30572092]
Allegedly, during a percutaneous nephrolithotomy procedure, the tip of a ultrasonic probe broke and fell off inside the patient's kidney; the surgeon was able to remove the piece and procedure was completed with no injury to patient.
Patient Sequence No: 1, Text Type: D, B5
[37887011]
Manufacturer's evaluation: the probe is broken at the distal end. A possible root cause for the broken distal end is overheating and/or mechanical overload. This is a user related handling issue.
Patient Sequence No: 1, Text Type: N, H10
[37887012]
Allegedly, during a percutaneous nephrolithotomy procedure, the tip of a ultrasonic probe broke and fell off inside the patient's kidney; the surgeon was able to remove the piece and procedure was completed with no injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2015-00092 |
| MDR Report Key | 5206774 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-06 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2015-10-05 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-11-06 |
| 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 GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer City | TUTTLINGEN, GERMANY, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASONIC PROBE |
| Generic Name | ULTRASONIC PROBE |
| Product Code | FEO |
| Date Received | 2015-11-06 |
| Returned To Mfg | 2015-10-15 |
| Model Number | 27093LL |
| Catalog Number | 27093LL |
| Lot Number | NU |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-06 |