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

Model Number 0620040610

Device Problems Pressure Problem (3012); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Respiratory Insufficiency (4462); Insufficient Information (4580)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was cancelled.

Manufacturer Narrative

Alleged failure: read incorrect, doc said was reading incorrect/they was how ever using a 3rd party tubing and not stryker/ salesforce case number (b)(4).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be a third party tubing used during the procedure and/or a loose adapter used during the procedure, as there were no findings during the functional testing of the unit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the procedure was cancelled.

• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13514735
• MDR Text Key: 285503938
• Report Number: 0002936485-2022-00073
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0620040610
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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