MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-30 for INTUBATION LARYNGOSCOPE 11301BN1 manufactured by Karl Storz Endoscopy-america, Inc..
[63769691]
Patient Sequence No: 1, Text Type: N, H10
[63769692]
During an attempt to intubate a patient the digital video intubation scope would not register or provide an image when anesthesiologist plugged device into the scope monitor port. After several attempts the scope was exchange for a fiber optic intubation scope and the patient was intubated and case proceeded. There was not patient harm in this event. Scope cleaned and sent to biomedical for evaluation. This was the second event this week on these digital scopes failing prior to use. Biomedical including a second scope in this report for manufacturer evaluation and report. Manufacturer response for digital video intubation scope, storz endoscope (per site reporter): manufacturer standard response is to send in for repair evaluation. Biomedical to request formal report. Manufacturer response for digital video intubation scope, (brand not provided) (per site reporter): standard mfg response of sending in unit for repair cost evaluation. Biomedical requesting formal report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6216247 |
| MDR Report Key | 6216247 |
| Date Received | 2016-12-30 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-12-19 |
| Report Date | 2016-12-20 |
| Date Reported to FDA | 2016-12-20 |
| Date Reported to Mfgr | 2016-12-20 |
| Date Added to Maude | 2016-12-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTUBATION LARYNGOSCOPE |
| Generic Name | LARYNGOSCOPE, NON-RIGID |
| Product Code | CAL |
| Date Received | 2016-12-30 |
| Model Number | 11301BN1 |
| Catalog Number | 11301BN1 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-30 |