MAUDE Adverse Event Report: STRYKER; INSUFFLATOR, AUTOMATIC CARBONDIOXIDE FOR ENDSCOPE

Device Problems Air Leak (1008); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

While the surgical case was in progress, the insufflation device stopped working.Surgeon lost air at a critical point during surgery while bleeding was occuring.Insufflation box showed 1/4 bar of co2 still remaining.Immediate troubleshooting action occurred including checking ports in patient for leak, switching co2 over to spare tank on tower, which did nothing and turning device off and back on.Equipment technician notified to come into room stat with additional co2 tank.He then switched tanks and it was noted that both of the original tanks still had co2 remaining.He also check all connections and turned machine off and back on.Machine still remained broken and showed 1/4 bar of co2 remaining.A few minutes went by and machine suddenly started working again.Dr.Involved with entire processes.No injury to patient.Clinical engineering checked and no problem found.Clinical engineering unable to duplicate event.

• Type of Device: INSUFFLATOR, AUTOMATIC CARBONDIOXIDE FOR ENDSCOPE
• Manufacturer (Section D): STRYKER; 5900 optical court; san jose CA 95138
• MDR Report Key: 5340082
• MDR Text Key: 34906473
• Report Number: 5340082
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Other Device ID Number: 13988021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 85