MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-08 for PNEUMO SURE HIGH FLOW INSUFFLATOR 0620040600 manufactured by Stryker Endoscopy San Jose.
[16744335]
Allegedly, the tubing does not stay on insufflator. Same tubing was used on other insufflators and they stayed on.
Patient Sequence No: 1, Text Type: D, B5
[16933827]
This unit was received for eval. The tube set used with this unit was not returned. An in-house tube set was used to conduct testing. Bottle gas was connected and the unit was tested in the high flow at different pressure and flow setting. For one of the settings a higher flow rate than normal was used in order to simulate the case situation. The reported failure could not be duplicated. The mostly likely cause of tubing not staying in the insufflator might be that of pulling and tugging on the tube set, tube set not connected. The tube set not connected error displays when the tube set is pulled or tugged in a manner such that the bottom part of the tube set adapter was pulled out. The sensor pin is present on the bottom part of the adaptor. If the bottom part of the adaptor is pulled out then the sensor would no longer detect the tube set hence giving an error and would stop insufflating. The root cause is the design of the tube set adaptor fit into the console coupled with the tube set detection mechanism. A new enhanced optical sensor tube set detection mechanism is in place which addresses this issue. In this design enhancement, instead of a mechanical switch an optical switch with improved gui is used. With this new design the sensor and latch are physically located next to each other, such that the sensor would detect the tube set as long as tube set is latched in.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2010-00073 |
| MDR Report Key | 1609520 |
| Report Source | 07 |
| Date Received | 2010-02-08 |
| Date of Report | 2008-07-24 |
| Date of Event | 2008-07-24 |
| Date Mfgr Received | 2008-07-24 |
| Date Added to Maude | 2010-10-13 |
| 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 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 | PNEUMO SURE HIGH FLOW INSUFFLATOR |
| Generic Name | INSUFFLATOR |
| Product Code | NKC |
| Date Received | 2010-02-08 |
| Catalog Number | 0620040600 |
| 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 | 2010-02-08 |