MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-27 for INNERVISION TRANSILLUMINATION SYSTEM 1465-50 165-50 manufactured by Diversatek Healthcare.
[118346180]
The customer reported a tear of the esophagus after the disposable tip detached from the device. The tear was repaired through endoscopic intervention. The customer believes the tip folded back on itself during passage through the esophagus. The device labeling indicates that the tip can come detached if the tip is bent at a significant angle within the patient. Disposable tips from the same manufacturing lot were examined and all specifications were within tolerances. Additionally, the device history record of the manufacturing lot was reviewed and no issues were recorded. The manufacturer also reviewed complaint trending reports. No similar issues have been reported in any complaint trends. Therefore, the manufacturer believes this to be an isolated incident. The device is not believed to have caused or contributed to the event. Diversatek has determined that there are no new safety or efficacy issues as a result of this event and therefore, no further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
[118346181]
Customer reported on mw5078295 the 50fr bougie tip became dislodged from the illumination cord in the patient's esophagus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183446-2018-00001 |
| MDR Report Key | 7820278 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-05-16 |
| Date Facility Aware | 2018-05-16 |
| Report Date | 2018-07-05 |
| Date Reported to FDA | 2018-07-05 |
| Date Reported to Mfgr | 2018-07-30 |
| Date Mfgr Received | 2018-07-30 |
| Device Manufacturer Date | 2018-03-27 |
| Date Added to Maude | 2018-08-27 |
| 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 | LAURA BOLL |
| Manufacturer Street | 102 E KEEFE AVE |
| Manufacturer City | MILWAUKEE WI 53212 |
| Manufacturer Country | US |
| Manufacturer Postal | 53212 |
| Manufacturer Phone | 4142657620 |
| Manufacturer G1 | DIVERSATEK HEALTHCARE |
| Manufacturer Street | 102 E KEEFE AVE |
| Manufacturer City | MILWAUKEE WI 53212 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNERVISION TRANSILLUMINATION SYSTEM |
| Generic Name | LIGHTED BOUGIE |
| Product Code | FDG |
| Date Received | 2018-08-27 |
| Model Number | 1465-50 |
| Catalog Number | 165-50 |
| Lot Number | 221575 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIVERSATEK HEALTHCARE |
| Manufacturer Address | 102 E KEEFE AVE MILWAUKEE WI 53212 US 53212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-27 |