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

Catalog Number 0620040610

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that while in use during a case, the patient went to cardiac arrest.The procedure was not completed due to patient coded.

Event Description

It was reported that while in use during a case, the patient went to cardiac arrest.The procedure was not completed due to patient coded.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure:patient was hooked on to the insufflator and it set at highflow.Then cardiac arrest took place then was removed from insufflator.Patient had health issues.The procedure was not completed due to patient coded.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be a small leak within the high pressure unit.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG; 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
• MDR Report Key: 7770735
• MDR Text Key: 116700097
• Report Number: 0002936485-2018-00576
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

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: 10/05/2018
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other