MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-07-12 for YAG DISPOSABLE FIBER DELIVERY 24620 AA2010300 manufactured by Esc/sharplan, Yokneam Industrial Park.
[20432223]
During a bronchoscopy, the tip of the fiber broke off in the trachea. There were less than 40 pulses on the fiber. The hosp retrieved the broken tip in the pt with no further pt complications or injury. This occurred twice with the same lot of fibers, one on may 13, 2000 and the second on may 25, 2000. The two incidents involved the use of a bronchoscope and passing the fibers throughout the working channel of the scope to treat the throat when the tips broke. Both tips were retrieved from the lungs with no residual effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1224847-2000-00002 |
| MDR Report Key | 286284 |
| Report Source | 05,06 |
| Date Received | 2000-07-12 |
| Date of Report | 2000-07-10 |
| Date of Event | 2000-05-13 |
| Date Facility Aware | 2000-06-19 |
| Report Date | 2000-07-10 |
| Date Reported to FDA | 2000-07-07 |
| Date Reported to Mfgr | 2000-07-10 |
| Device Manufacturer Date | 2000-07-01 |
| Date Added to Maude | 2000-07-21 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ZVI LADIN |
| Manufacturer Street | 100 MORSE STREET |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812787600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YAG DISPOSABLE FIBER DELIVERY |
| Generic Name | FIBER CABLE |
| Product Code | GDB |
| Date Received | 2000-07-12 |
| Returned To Mfg | 2000-07-18 |
| Model Number | 24620 |
| Catalog Number | AA2010300 |
| Lot Number | 1254/07/99 |
| ID Number | * |
| Device Expiration Date | 2004-07-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 277030 |
| Manufacturer | ESC/SHARPLAN, YOKNEAM INDUSTRIAL PARK |
| Manufacturer Address | P.O.B. 240 YOKNEAM IS 20692 |
| Baseline Brand Name | OPTICAL FIBER DELIVERY |
| Baseline Generic Name | FIBER OPTIC SYSTEM |
| Baseline Model No | 24620 |
| Baseline Catalog No | AA 2010300 |
| Baseline Device Family | FIBERS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 5 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-12 |