MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for LIGHT SOURCE, 300 WATT XENON W/SCB 201331-20-1 manufactured by Karl Storz Endovision.
[124476851]
The light source was returned and evaluated; our findings were as follows: all output readings are below spec. Unit was received in with a different lamp installed than what our records show we installed when we last serviced the light source in july 2016; also, the lamp differs from what karl storz recommends. Lamp output is not meeting spec. Lumen reading: 1113 actual; spec rating 1530-2800. Optical power 1. 9 actual; spec rating 5. 1 max. In addition, the model numbers for the light cable and arthroscope used for the procedure, which were provided to us by the hospital, are not of our manufacturer; the light cable, model #wa03310a, we believe is an olympus light cable; the arthroscope, model #502104030, is a stryker model number. There was no reported malfunction of the light source. The burn injury most likely occurred as a result of the light cable's connector coming into contact with the patient.
Patient Sequence No: 1, Text Type: N, H10
[124476852]
Allegedly, the patient sustained a 3rd degree burn under her arm during a rotator cuff arthroscopy procedure; the burn was noticed by the patient the day after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221826-2018-00082 |
| MDR Report Key | 7986369 |
| Date Received | 2018-10-19 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2018-09-20 |
| Device Manufacturer Date | 2015-05-11 |
| Date Added to Maude | 2018-10-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 ENDOVISION |
| Manufacturer Street | 91 CARPENTER HILL ROAD |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGHT SOURCE, 300 WATT XENON W/SCB |
| Generic Name | LIGHT SOURCE |
| Product Code | FFS |
| Date Received | 2018-10-19 |
| Returned To Mfg | 2018-10-01 |
| Model Number | 201331-20-1 |
| Catalog Number | 201331-20-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | 91 CARPENTER HILL ROAD CHARLTON MA 01507 US 01507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-19 |