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 Extravasation (1842)

Event Date 10/22/2014

Event Type  Injury  

Event Description

It was reported that the patient experienced extravasation during a procedure.There was a delay in the procedure, but the procedure was completed successfully.

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: insufflator received with house gas connector and functional adapter.The warranty seal was unbroken.The calibration sticker on the back of the unit indicates it is not overdue for calibration because the due date was may, 2015.Physical damage observed on the chassis cover, bottom chassis, and hpu area.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 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.Customer settings used for burn-in test.The insufflator underwent a ¿burn-in¿ test in which it was connected to a gas bottle that had a compressed gas regulator connected in order to convert it to house gas pressure.After the bottle was opened, the console was left running for 72 hrs.A tube set that is connected to a dummy lap fixture was inserted into the insufflator, and was run with a set pressure of 22 mm hg while in high flow insufflation in order to check for pressure issues.The insufflator completed this test with no issues observed.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 with a set pressure of 10 mm hg, 20 mm hg, and 30 mm hg while in veress insufflation.In addition, 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 tolerance when running in veress insufflation).Refer to the attached pressure readings.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 tolerance when running in high flow insufflation).Refer to the attached pressure readings.Based on the testing performed, the insufflator functioned properly without any incident.Although the customer complaint was not reproduced, physical damage was observed on the insufflator.This may cause sensor drifts or valve errors, which can result in nonconforming behavior including, but not limited to, the cessation of gas flow.The probable root causes for the extravasation could be due to physical damage to the insufflator or unintentional manipulation of the abdomen.The probable root causes for the physical damage could be due to dropping/banging of the device against a hard surface or shipping issue.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.       .

Event Description

It was reported that the patient experienced extravasation during a procedure.There was a delay in the procedure, but the procedure was completed successfully.

• 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: 4277774
• MDR Text Key: 5029029
• Report Number: 0002936485-2014-00958
• 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: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• 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: 11/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2014
• 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