MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMO SURE HIGH FLOW INSUFFLATOR W/ SIDNE (EU1); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040601

Device Problem Insufficient Information (3190)

Patient Problem Electrolyte Imbalance (2196)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

It was reported that during a surgery the patient's ph changed due to high co2 resorption.

Event Description

It was reported that during a surgery the patient's ph changed due to high co2 resorption.

Manufacturer Narrative

The reported device was not received for investigation; therefore, the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: bad lpu/hpu; bad pressure sensors or pressure control valves; use error; over due for calibration.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

• Brand Name: PNEUMO SURE HIGH FLOW INSUFFLATOR W/ SIDNE (EU1)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 3844352
• MDR Text Key: 4659716
• Report Number: 0002936485-2014-00382
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 06/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1