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 Cardiopulmonary Arrest (1765)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

The product was returned for investigation and the failure mode was not confirmed.Alleged failure: equipment used when patient "coded".Calling in just in case.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause as the unit passed the specific, functional tests for this product as per user manual 1000401015 and service guide 1000401064.Therefore, this unit is deemed as no problem found.(b)(4).The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the patient "coded" while this device was being used.Per additional information received, the procedure was completed successfully.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: sandhya jaishankar ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6980566
• MDR Text Key: 90344638
• Report Number: 0002936485-2017-01007
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

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: 10/05/2017
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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