MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-04-27 for INFRAVISION 56 FR. ESOPHAGEAL KIT (5BX) 0220180540 manufactured by Stryker Endoscopy San Jose.
[1547396]
It was reported that there were two instances where patients coughed up the sheath of the e-kit. No other details were available at this time.
Patient Sequence No: 1, Text Type: D, B5
[8645636]
Add'l info will be provided once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2010-00343 |
| MDR Report Key | 1675714 |
| Report Source | 07 |
| Date Received | 2010-04-27 |
| Date of Report | 2010-04-14 |
| Date of Event | 2010-04-14 |
| Date Mfgr Received | 2010-04-14 |
| Date Added to Maude | 2010-09-16 |
| 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 | 0 |
| Manufacturer Contact | SONNY OFFORJEBE |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFRAVISION 56 FR. ESOPHAGEAL KIT (5BX) |
| Generic Name | CATHETER |
| Product Code | FAT |
| Date Received | 2010-04-27 |
| Catalog Number | 0220180540 |
| Lot Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-27 |