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

Model Number 0620040610

Device Problems Decrease in Pressure (1490); Increase in Pressure (1491); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the procedure was converted to open surgery.

Event Description

It was reported the procedure was converted to open surgery.

Manufacturer Narrative

Alleged failure: during case, the pressure was set to 15 but actual was 0-20 and would jump/drop in a couple of seconds.Flow was doing the same.Tried a different tube set but did not help.Brought in another insufflator and the same thing happened.After about 10 minutes of troubleshooting and no success, surgery went from laparoscopic to open.Per rep about 15-30 min of delay.Occurred at 9:30am cst.Unknown at this time about success of case.Salesforce case number (b)(4) case successful after open per rep the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as there were no errors or observances which occurred during the functional testing of the unit.However, it is recommended to replace the gas adapter as the sinter filter of the gas adapter is dirty.The product was returned for investigation and the 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: 11463967
• MDR Text Key: 239166464
• Report Number: 0002936485-2021-00136
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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 Model Number: 0620040610
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other