FDA Adverse Event
Malfunction
Summary report: N
HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK)
MDR report key: 2090532
·
Received April 19, 2011
Report
- Report Number
- 2936485-2011-00241
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PRODUCT KEEPS COMING OFF THE TROCARS AND CAUSES AT LEAST 1 MINUTE DELAYS FOR THE SURGEON TO RE-INSUFFLATE THE PT. IT WAS FURTHER REPORTED THAT THE PRODUCT IS PRETTY STIFF AND THE LUER LOCK WORKS ITSELF OFF AFTER A WHILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK) | TUBESET | GCJ | STRYKER ENDOSCOPY SAN JOSE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |