MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-07 for 5.0MM X 7.5FT NON-TRANSPARENT FIBEROPTIC CABLE 0233050084 manufactured by Stryker Endoscopy-san Jose.
[4860293]
It was reported that after the procedure, a slight burn was observed on the skin of the patient. It was further reported that the adapter was placed on the drape that was on the patient. A scope along with a lightsource were used together and the setting on the lightsource was stated to be set at 80.
Patient Sequence No: 1, Text Type: D, B5
[12184178]
The reported device was not received for investigation; therefore, the reported failure cannot be confirmed. The complaint will be closed without a detailed investigation report and based on probable root cause. In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results. Probable root cause for the reported failure involving this device could have been caused by: user misuse/mishandling (leaving the scope on the patient while the light was on). In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.
Patient Sequence No: 1, Text Type: N, H10
[21447263]
It was reported that after the procedure, a slight burn was observed on the skin of the patient. It was further reported that the adapter was placed on the drape that was on the patient. A scope along with a lightsource were used together and the setting on the lightsource was stated to be set at 80.
Patient Sequence No: 1, Text Type: D, B5
[21737911]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2014-00190 |
| MDR Report Key | 3730228 |
| Report Source | 07 |
| Date Received | 2014-04-07 |
| Date of Report | 2014-03-12 |
| Date of Event | 2014-03-12 |
| Date Mfgr Received | 2014-03-12 |
| Date Added to Maude | 2014-04-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS SHAFER |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.0MM X 7.5FT NON-TRANSPARENT FIBEROPTIC CABLE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2014-04-07 |
| Catalog Number | 0233050084 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-07 |