MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-05 for INFRAVISION 56 FR. ESOPHAGEAL KIT (5BX) 220180540 manufactured by Stryker Endoscopy San Jose.
[1425178]
Balloon ruptured. It was reported that when using the e-kit, the balloon ruptured at 48ml inside the patient. The 2nd occurrence happened on (b)(6)- it was reported that they slowly inflated the e-kit to 50ml and as it was going up to the last 7ml, it started to leak.
Patient Sequence No: 1, Text Type: D, B5
[8456270]
As part of a quality system improvement plan, stryker corporation conducted a 2 year retrospective mdr review to ensure appropriate mdr reporting decisions. Events reported to stryker from 07/01/2006 to 07/01/2008 were the scope of this retrospective review. These events are being submitted under exemption (b)(4). There is one event associated with this event type (malfunction) and product code fat.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2009-00427 |
| MDR Report Key | 1621952 |
| Report Source | 07 |
| Date Received | 2010-02-05 |
| Date of Report | 2010-02-05 |
| Date of Event | 2006-10-12 |
| Date Added to Maude | 2011-04-06 |
| 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 | NILA PATEL |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFRAVISION 56 FR. ESOPHAGEAL KIT (5BX) |
| Generic Name | INSTRUMENT |
| Product Code | FAT |
| Date Received | 2010-02-05 |
| Returned To Mfg | 2006-11-20 |
| Model Number | NA |
| Catalog Number | 220180540 |
| Lot Number | NI |
| ID Number | FAT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-02-05 |