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

Catalog Number 0620040610

Device Problem Increase in Pressure (1491)

Patient Problem Distress (2329)

Event Date 06/08/2015

Event Type  Injury  

Event Description

It was reported that the insufflator pressure spiked up to 17 on a low flow, and the patient went into distress.

Manufacturer Narrative

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

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: the insufflator was received with a back gas connector.The warranty seal was unbroken.The calibration sticker on the back of the insufflator indicates it is not overdue for calibration because the due date is (b)(6) 2015.There was no physical damage to the insufflator.All pcba's were undamaged, and all cables were seated properly.Functional inspection: testing was performed to replicate the complaint and is mentioned below.The insufflator underwent 20 power cycles.Per each power cycle, the insufflator performed a device check (verifies proper function of electronics, sensors, and valves).The insufflator completed the test with no error messages or issues observed.The insufflator was set to pediatric mode for the burn-in test.The insufflator underwent a burn-in test in which a tube set that was connected to a dummy lap fixture was inserted into the insufflator.Also, a gas bottle was connected to the insufflator and then opened.Started the insufflator with a set pressure of 8 mm hg while in pediatric insufflation and then left the insufflator running for 72 hrs.The insufflator completed the test with no deviations or issues observed.The insufflator was set to pediatric mode for the lpu venting system and pressure alarm test.A tube set that was connected to a dummy lap fixture was inserted into the insufflator with a pressure sensor transducer connected.Also, a gas bottle was connected to the insufflator and then opened.The insufflator was then run with a set pressure of 8 mm hg while in pediatric insufflation.Dummy lap depressions were applied in order to verify if the overpressure alarm would sound as well as trigger the venting valve.While maintaining dummy lap depressions, the overpressure alarm sounded, and the venting valve triggered which vented the excess pressure back to the set pressure of about +/- 2 mm hg (which is an acceptable tolerance when running in pediatric insufflation).Refer to the attached pressure reading.The insufflator was received with the following software version: f05 034 ca 0509.Based on the testing performed, the insufflator functioned properly without any incident.The probable root cause for the reported failure involving this device could be due to unintentional manipulation of the abdomen.

Event Description

It was reported that the insufflator pressure spiked up to 17 on a low flow, and the patient went into distress.

• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4872835
• MDR Text Key: 5862763
• Report Number: 0002936485-2015-00541
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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
• Patient Outcome(s): Other