MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for 1392 5.9MM STRYKER SHEATH 2 WAY -NS 281392 manufactured by Depuy Mitek Llc Us.
[136859914]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[136859915]
It was reported during an unknown procedure the 5. 9 nn stryker sheath coupler was broken causing it now to hold the lens. The procedure was completed using a like device. There was no patient consequence or surgical delay. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-53724 |
| MDR Report Key | 8290838 |
| Date Received | 2019-01-30 |
| Date of Report | 2017-05-08 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2010-09-24 |
| Date Added to Maude | 2019-01-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY MITEK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 1392 5.9MM STRYKER SHEATH 2 WAY -NS |
| Generic Name | RIGID ENDOSCOPE SHEATH |
| Product Code | HNX |
| Date Received | 2019-01-30 |
| Returned To Mfg | 2017-05-25 |
| Catalog Number | 281392 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-30 |