MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for STRYKER PNEUMOCLEAR HIGH FLOW TUBE SET REF 0620050100 manufactured by Stryker Endoscopy.
[177399307]
Rn attempted to turn on the insufflation. The monitor was saying "invalid". She unplugged it, turned the machine off and back on and the same error popped up. She then changed the insufflation tubing and the error did not appear. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092665 |
| MDR Report Key | 9653771 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-11-19 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | STRYKER PNEUMOCLEAR HIGH FLOW TUBE SET |
| Generic Name | INSUFFLATOR, LAPAROSCOPIC |
| Product Code | HIF |
| Date Received | 2020-01-30 |
| Catalog Number | REF 0620050100 |
| Lot Number | 4016548 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |