MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-19 for 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE 0233050069 manufactured by Stryker Endoscopy-san Jose.
[5216639]
It was reported that the light was still on and was not placed on standby. The patient's right wrist was left with a burn.
Patient Sequence No: 1, Text Type: D, B5
[12614665]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[23929670]
Fiber optic cable catalog no. 0233050069 lot# 084190 rma# (b)(4) was returned to stryker for analysis. The customer complaint of? Patient burn? Was detailed in the complaint description; not via testing. Visual inspection: did not reveal any physical or cosmetic issues with the product. Functional inspection: the cable was illuminated using an l9000 light source; the product had approximately (50-60) broken fibers which caused the light cable to have a lower than normal lumen output; most returned cables in that condition have been due to long usage breakdown of the fibers. Temperature measurements were performed and the temperature at the tip of the cable measured 80 degrees c; the same as a new out-of-box cable. Therefore, the cable did not present any additional risk to the patient. Probable root cause: possible misuse of the product; the complaint states that the light source was not put in standby mode prior to coming into contact with the patient. The product was returned for investigation and the reported failure mode was confirmed. The failure mode will be monitored for future reoccurrence.???????
Patient Sequence No: 1, Text Type: N, H10
[23929671]
It was reported that the light was still on and was not placed on standby. The patient's right wrist was left with a burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2014-01031 |
| MDR Report Key | 4348616 |
| Report Source | 05 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-12-12 |
| Date of Event | 2014-12-12 |
| Date Mfgr Received | 2014-12-12 |
| Date Added to Maude | 2014-12-22 |
| 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 |
| 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 | 2014-12-19 |
| Returned To Mfg | 2015-01-12 |
| Catalog Number | 0233050069 |
| Lot Number | 084190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-12-19 |