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

Catalog Number 0620040610

Device Problem Insufficient Information (3190)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 09/05/2014

Event Type  Injury  

Event Description

It was reported that the patient coded while the unit was turned on.

Manufacturer Narrative

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

Manufacturer Narrative

The product was returned and the failure mode was not confirmed.Visual inspection: 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 march, 2016.The insufflator was undamaged.Also, all pcba¿s were undamaged, and all cables were properly seated.Functional inspection: testing was performed to replicate the complaint and is mentioned below.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 with a pressure sensor transducer connected.Also, a gas bottle was connected to the insufflator and opened.The insufflator was then started and left running for 72 hrs with a set pressure of 15 mm hg while in high flow insufflation in order to check for pressure issues.The insufflator completed this test with no issues observed.The insufflator underwent 20 power cycles.Per each power cycle, the insufflator performed a device check (verifies proper function of electronics, sensors, and valves).No error messages or issues were observed during testing.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 opened.The insufflator was then run and dummy lap depressions were applied in order to verify if the overpressure alarm would sound.The overpressure alarm sounded.When the dummy lap depressions were stopped, the insufflator was then able to revert to the set pressures of about +/- 2 mm hg (which is an acceptable variation when running in veress insufflation).While in high flow insufflation and with the same set pressures as previously mentioned, dummy lap depressions were also 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 pressures of about +/- 2 mm hg (which is an acceptable variation when running in high flow insufflation).Additional testing was performed to replicate the complaint and is mentioned below.(b)(4).The insufflator was received with the following software version: (b)(4).The customer complaint was not confirmed.Based on the testing performed, the insufflator functioned properly without any incident.The probable root cause for the customer complaint is likely due to use error.In sum, the product was returned and the failure mode was not confirmed.

Event Description

It was reported that the patient coded while the unit was turned on.

• 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: 4127154
• MDR Text Key: 4796513
• Report Number: 0002936485-2014-00761
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2014
• 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