MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-10-25 for INFRAVISION 60 FR. ESOPHAGEAL KIT (5BX) 0220180560 manufactured by Stryker Endoscopy San Jose.
[1693757]
It was reported that after the product was used in a procedure, the sheath on the product had slipped off into the stomach of the pt. It was further reported that the sheath was removed from the pt. It was confirmed that no other parts remained in the pt.
Patient Sequence No: 1, Text Type: D, B5
[8918636]
Add'l info will be provided once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2010-00789 |
| MDR Report Key | 1885975 |
| Report Source | 07 |
| Date Received | 2010-10-25 |
| Date of Report | 2010-10-12 |
| Date of Event | 2010-10-12 |
| Date Mfgr Received | 2010-10-12 |
| Date Added to Maude | 2011-03-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUNNY 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 60 FR. ESOPHAGEAL KIT (5BX) |
| Generic Name | CATHETER |
| Product Code | FAT |
| Date Received | 2010-10-25 |
| Catalog Number | 0220180560 |
| Lot Number | 999999 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2010-10-25 |