MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for STRYKER INSUFFLATION TUBING manufactured by Stryker Endoscopy.
[138910096]
Sds team opened one of the insufflation tubing and it was leaking around where it plugs into the machine. The lot #56005247, exp. Date 02/09/2020. This is in the team leaders office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084890 |
| MDR Report Key | 8420638 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-02-27 |
| Date Added to Maude | 2019-03-14 |
| 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 | 0 |
| Brand Name | STRYKER INSUFFLATION TUBING |
| Generic Name | TUBING / TUBING WITH FILTER, INSUFLLATION LAPAROSCOPIC |
| Product Code | NKC |
| Date Received | 2019-03-13 |
| Lot Number | 56005247 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |