MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-24 for 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE 0233050064 manufactured by Stryker Endoscopy-san Jose.
[4240540]
It was reported that the patient sustained a skin injury to her right medial malleolus when the light cord of the endoscopic vein harvesting apparatus unscrewed from the scope and landed on the patient's leg. The endoscopic harvesting apparatus was set down while the operator prepared the drain for insertion. The light cord and scope were intact, meaning the cord was attached to the scope, at the time the apparatus was set down. When going to pick up the apparatus for use, the operator noted that the light cord had become dislodged (unscrewed) from the scope. The patient sustained a small dry blister about 0. 5 centimeters with no redness to the right medial malleolus. The patient suffered a second degree burn. This happens on occasion and the cord and scope are reconnected. In this instance, the cord separated after the scope was placed down for a brief time and fell onto an exposed area of skin by the ankle.
Patient Sequence No: 1, Text Type: D, B5
[11669917]
The product was not returned for investigation. The reported failure mode could not be confirmed. Based on previous investigations, probable root causes may be associated to but not limited to: safelight design, boot material, light source, and/or use error. However, this cannot be confirmed since the unit was not returned. In the event that the unit is returned, a full evaluation will be conducted and a follow up report will be issued. In sum, 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
[22136000]
It was reported that the patient sustained a skin injury to her right medial malleolus when the light cord of the endoscopic vein harvesting apparatus unscrewed from the scope and landed on the patient's leg. The endoscopic harvesting apparatus was set down while the operator prepared the drain for insertion. The light cord and scope were intact, meaning the cord was attached to the scope, at the time the apparatus was set down. When going to pick up the apparatus for use, the operator noted that the light cord had become dislodged (unscrewed) from the scope. The patient sustained a small dry blister about 0. 5 centimeters with no redness to the right medial malleolus. The patient suffered a second degree burn. This happens on occasion and the cord and scope are reconnected. In this instance, the cord separated after the scope was placed down for a brief time and fell onto an exposed area of skin by the ankle.
Patient Sequence No: 1, Text Type: D, B5
[22308857]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2014-00076 |
| MDR Report Key | 3641096 |
| Report Source | 04 |
| Date Received | 2014-02-24 |
| Date of Report | 2014-01-27 |
| Date of Event | 2013-12-16 |
| Date Mfgr Received | 2014-01-27 |
| Date Added to Maude | 2014-02-24 |
| 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 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2014-02-24 |
| Catalog Number | 0233050064 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-02-24 |