MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-16 for FIBER OPTIC LIGHT CABLE 495UDL manufactured by Karl Storz Se & Co. Kg.
[183568402]
The devices were described with karl storz brand name but without model number and there is no contact information for us to follow up with the customer. We suspect they were our light cable item 495udl (bifurcated fiber optic, cable) connected to the ureteral probe 496u (ureter probe illuminated) and to the integra luxtec portable light source. We suspect the light cable and probe connector was in contact with the patient's thigh and resulted in the burn, we therefore file this event on the light cable. Our ifu 97000213 v3. 0 (11-2017) warns the user not to rest the light cable on the patient for risk of injury.
Patient Sequence No: 1, Text Type: N, H10
[183568403]
We received medwatch report mw5092762, it stated a patient sustained a burn on the left thigh after ureteral lighted stents connected to a portable light box were taped to the thigh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2020-00035 |
| MDR Report Key | 9835664 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2020-03-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2188201 |
| Manufacturer G1 | KARL STORZ SE & CO.KG |
| Manufacturer Street | DR.-KARL-STORZ -STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, GM, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBER OPTIC LIGHT CABLE |
| Generic Name | LIGHT CABLE BIFURCATED AT TELESCOPE END 3.5 X 300CM |
| Product Code | FCW |
| Date Received | 2020-03-16 |
| Model Number | 495UDL |
| Catalog Number | 495UDL |
| Lot Number | ZT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |