MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-06 for FIBER-OPTIC LIGHT CABLE 3.5MMX7.5FT A/A 88-9760 manufactured by Carefusion, Inc.
[130470067]
Pr# (b)(4) the sample was provided, and an evaluation was performed. The root cause of the reported issue is due to improper use of the product. Damaged glass fiber is not a failure under normal use and proper care. Cable has excessive glass fiber damage and may be due to mishandling of cable. The device has approximately 70% damaged glass fiber. This amount of damage can cause heat to escalate into the end tips of the cable. According to the ifu for this device, it states to always inspect cables for any evidence of damage prior to use, looking for scratches or dings. The supplier? S acceptance criteria for light guide cables are no more than 6 broken fibers. Mishandling of fiberoptic cables, such as bending into a tight radius, dropping from a distance or excessive crimping, can and will cause the fibers to break, which in turn can cause more heat to be displaced at the tips. Based on the evaluation, this cable was not in proper condition to be used and should have been discarded. There have been no issues identified with the material or manufacturing process. A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[130470068]
Sales rep reported via email: can see fibers in the cord breaking. Surgeon reported that cord became too hot during use and had to put a wet, cold cloth over it, so he didn? T burn his hand. Per form surgeon burnt hand. (b)(6) 2018 additional information: please confirm whether there was any patient impact. No patient impact. (b)(6) 2018 additional information: 1. Was the product received in this condition? No. 2. If not, what was the product being used for when it was observed that the cord became too hot during use? It was being used in the breast procedure. 3. Please confirm whether there was any patient impact. No patient impact but drapes on the patient and the surgeon? S hand holding the retractor. 4. There is conflicting information on the form. Did the surgeon burn his hand? Not that i am aware of. He stated that the retractor was too hot to hold. We have replaced/ purchased these cords an average of 90 days because the fibers break so easily and they get too hot to fast. (b)(6) 2018 additional information: could you give additional details on what happened to the drape during surgery? I understand it to be scorch, brown lines on the patient's drapes. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2018-00023 |
| MDR Report Key | 8137841 |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2018-12-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FIBER-OPTIC LIGHT CABLE 3.5MMX7.5FT A/A |
| Generic Name | LIGHT, SURGICAL, FIBEROPTIC |
| Product Code | FST |
| Date Received | 2018-12-06 |
| Catalog Number | 88-9760 |
| Lot Number | WO145164 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-06 |