MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-18 for 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE 0233050064 manufactured by Stryker Endoscopy-san Jose.
[4242504]
It was reported that the light cable, which was plugged into a light source, burnt the thumb of the scrub tech near the end of a hysterectomy procedure when the user was switching from a laparoscopic scope to a cystoscope.
Patient Sequence No: 1, Text Type: D, B5
[4717653]
It was reported that the light cable, which was plugged into a light source, burnt the thumb of the scrub tech near the end of a hysterectomy procedure when the user was switching from a laparoscopic scope to a cystoscope.
Patient Sequence No: 1, Text Type: D, B5
[11572434]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[12312258]
The device was not returned to stryker endo for investigation, therefore, the failure mode could not 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 a lightsource malfunction and/or user error. The product was not returned for investigation and the reported failure mode could not be confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2014-00140 |
| MDR Report Key | 3684208 |
| Report Source | 05 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-25 |
| Date of Event | 2014-02-25 |
| Date Mfgr Received | 2014-02-25 |
| Date Added to Maude | 2014-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2014-03-18 |
| Catalog Number | 0233050064 |
| Lot Number | 233-050-064 |
| 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 | 2014-03-18 |