MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-10-16 for ENDOLUMINA II TRANSILLUMINATION SYSTEM 56 FRENCH E 5630 manufactured by Bioenterics Corporation.
[17104847]
It was reported by the initial reporter that when the surgeon removed the transilluminating cable from the patient the device's tip became detached. Endoscopy was performed to retrieve the tip. The pt was not injured. There was no deterioration of the patient's health reported in association with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2026145-2001-00005 |
| MDR Report Key | 356476 |
| Report Source | 07 |
| Date Received | 2001-10-16 |
| Date of Report | 2001-10-10 |
| Date of Event | 2001-08-29 |
| Date Mfgr Received | 2001-08-31 |
| Date Added to Maude | 2001-10-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DOREEN PIERPOINT, COORDINATOR |
| Manufacturer Street | 1035 CINDY LANE |
| Manufacturer City | CARPINTERIA CA 93103 |
| Manufacturer Country | US |
| Manufacturer Postal | 93103 |
| Manufacturer Phone | 8056843045 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOLUMINA II TRANSILLUMINATION SYSTEM |
| Generic Name | TRANSILLUMINATING BOUGIE CABLE |
| Product Code | HBI |
| Date Received | 2001-10-16 |
| Returned To Mfg | 2002-02-28 |
| Model Number | 56 FRENCH |
| Catalog Number | E 5630 |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 345705 |
| Manufacturer | BIOENTERICS CORPORATION |
| Manufacturer Address | 1035 CINDY LANE CARPINTERIA CA 93013 US |
| Baseline Brand Name | ENDOLUMINA II TRANSILLUMINATION SYSTEM |
| Baseline Generic Name | TRANSILLUMINATING BOUGIE CABLE |
| Baseline Model No | 56 FRENCH |
| Baseline Catalog No | E-5630 |
| Baseline ID | TIP L/N S99ET05 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-10-16 |