MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for FLEXIBLE INTUBATION VIDEO ENDOSCOPE 11302BDX manufactured by Karl Storz Endovision.
[101583486]
The dymax adhesive was chipped off at two locations: one ( about 0. 14 mm) at distal end of the angle cover, about 7 mm from the distal end of the scope; the other one at the proximal end of angle cover, about 45 mm from distal end of the scope. There is an external cut in the angle cover that is 20 mm from the distal tip, causing an angle cover leak.
Patient Sequence No: 1, Text Type: N, H10
[101583487]
Allegedly, video scope was used during a bronchoscopy for double lumen placement, the doctor noticed that a fragment or small piece of a blue material had come loose from the scope and was retained in patient's trachea. They brought in another scope to complete the procedure. The chief of anesthesia confirmed that physician does not have plans to remove the piece that stayed in the patient. The doctor believes that patient will cough up the piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221826-2018-00016 |
| MDR Report Key | 7305006 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-01 |
| Device Manufacturer Date | 2014-12-09 |
| Date Added to Maude | 2018-02-28 |
| 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 | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188100 |
| Manufacturer G1 | KARL STORZ ENDOVISION |
| Manufacturer Street | 91 CARPENTER HILL ROAD |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEXIBLE INTUBATION VIDEO ENDOSCOPE |
| Generic Name | VIDEO ENDOSCOPE |
| Product Code | CAL |
| Date Received | 2018-02-28 |
| Returned To Mfg | 2018-02-20 |
| Model Number | 11302BDX |
| Catalog Number | 11302BDX |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | 91 CARPENTER HILL ROAD CHARLTON MA 01507 US 01507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |