MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-02-03 for ENDOLUMINA II TRANSILLUMINATED BOUGIE 56 FRENCH E-5630 manufactured by Bioenterics Corporation.
[124793]
Physician reported that on three separate occasions and during procedures, the detachable tips came off of the endolumina(r) ii transilluminated bougie's (eib ii) transilluminator cable, 56 french size. The surgeon reported that after insertion down the pt's esophagus and while attempting to remove the devices, the tips came off the cable connector and remained in the pt. The surgeon reported this occurred in three separate surgical procedures: (1)paraesophageal hernia repair and endoscopy was required to remove the tip, (2)nissen fundoplication and the tip was removed from the oral pharynx with a grasping instrument, and (3)nissen fundoplication and endoscopy was required to remove the tip from the pt's stomach. The physician reported that they are not reusing the tips and are disposing of them after surgery. With the first and second procedures, the tips were discarded; however, the tip from the third procedure and the transilluminator cable was returned to bioenterics corporation for evaluation. The physician reported that he has performed 28 nissen procedures. He indicated that the first two incidents may have been technique related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028368-1998-00001 |
| MDR Report Key | 148559 |
| Report Source | 05 |
| Date Received | 1998-02-03 |
| Date of Report | 1998-01-06 |
| Date Mfgr Received | 1998-01-06 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 1998-02-13 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOLUMINA II TRANSILLUMINATED BOUGIE |
| Generic Name | TRANSILLUMINATING BOUGIE |
| Product Code | KCD |
| Date Received | 1998-02-03 |
| Returned To Mfg | 1998-01-13 |
| Model Number | 56 FRENCH |
| Catalog Number | E-5630 |
| Lot Number | B97ET051 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 144764 |
| Manufacturer | BIOENTERICS CORPORATION |
| Manufacturer Address | 1035 CINDY LANE CARPINTERIA CA 93013 US |
| Baseline Brand Name | ENDOLUMINA II TRANSILLUMINATED BOUGIE |
| Baseline Generic Name | TRANSILLUMINATING BOUGIE |
| Baseline Model No | 56 FRENCH |
| Baseline Catalog No | E-5630 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1998-02-03 |