MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMO SURE XL HIGH FLOW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040610

Device Problem Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Visual inspection: broken warranty seal observed.The calibration sticker on the back of the insufflator indicates overdue calibration because the due date on the sticker shows december of 2012.No physical damage observed throughout the insufflator.All pcba¿s intact and observed no loose cables.Functional inspection: although there were no out of specification pressure readings, the insufflator failed step 13.6 of the user guide (max device pressure test).The pulse was irregular along with the pressure not stabilizing.Lpu calibration performed via service manual to see if this would fix the issue.Despite calibrating the lpu, still encountered the same issue as previously mentioned.The insufflator was received with the following software version: (b)(4).Although the customer complaint was not reproduced, the insufflator failed step 13.6 of the user guide (max device pressure test).The probable root cause for the reported failure involving this device could be due to an lpu failure.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the pneumosure kept insufflating past the set pressure.

• Brand Name: PNEUMO SURE XL HIGH FLOW INSUFFLATOR
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5244475
• MDR Text Key: 32135785
• Report Number: 0002936485-2015-01068
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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