MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-22 for TEBBETTS FIBEROPTIC SS RETR 15CMX30MM 88-1088 manufactured by Carefusion, Inc.
[73800428]
(b)(4); the instrument has not been returned for evaluation and no lot number could be provided. A shipping return label has been provided by international liaison for return of the device for investigation. If any additional information becomes available a follow up mdr report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[73800429]
Medical specialties - broken; according to the pictures, the sample looks broken. Additional information provided by the user facility 10apr2017: patient injured; metal powder inside the breast pouch, several irrigation needed, cleaning, aspiration. Alert date for mdr reportability is 10apr2017; additional information which determined the event to be mdr reportable was provided by user facility.
Patient Sequence No: 1, Text Type: D, B5
[77951556]
(b)(4); upon examination of the device it was observed that the device was of an older design and was extremely worn and rusted. The device arrived completely broken in two pieces with metal peeling up at the break. The device gold plating was faded and fiber optics were heavily contaminated with rust. The area where the device lot number is contained was extremely worn therefore a lot number was not visible. The lot number was either removed by user or became faded over time due to years of poor re-processing techniques or maintenance habits. Based on the observations of the device the retractor was very old. As the age, usage, or re-processing techniques are unknown the failure of the device is most likely due to poor cleaning, maintenance and processing over a long period of time. The caked up rust on the fiber optics indicates the device likely remained in stagnant water or solution longer than what is required in the instructions for use (ifu). Since the device lot number could no longer be observed on the instrument bd was unable to determine the age or traceability for the instrument and device history record review could not be performed. Because of the age, wear, and poor cleaning / maintenance practices through the instruments life cycle the device has reached end of life.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2017-00113 |
| MDR Report Key | 6513862 |
| Date Received | 2017-04-22 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-03-02 |
| Date Mfgr Received | 2017-04-10 |
| Date Added to Maude | 2017-04-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER GA 30084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEBBETTS FIBEROPTIC SS RETR 15CMX30MM |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2017-04-22 |
| Model Number | 88-1088 |
| Catalog Number | 88-1088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-04-22 |