MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040611

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was inlet gas pressure issue.

Event Description

It was reported that there was inlet gas pressure issue.

Manufacturer Narrative

The device was received at the local service facility for investigation.The technical service report indicates: the device was not received for investigation at stryker endoscopy because it was repaired locally in stryker uk.The technical service report indicates: summary of evaluation - with gas bottle connected and open and insufflator switched off completed soak test of hpu initial pressure reading 57 bar - 48hrs later still reading 57 bar = no loss of pressure.With gas bottle connected and open and insufflator switched off and manometer connected to the hpu output pressure reading at the manometer was was 2.4 bar closed gas bottle, after 1 hour reading at manometer was 2.4 bar e63 error during testing which relates to a failed lpu - patient pressure sensor amplification too high - replaced the lpu updated software 0513-0514 supplied brand new tube adaptor - z146539 est 113309 device will be returned to the customer probable root cause: 1.Tolerance stack up issue (tubeset design) 2.Manufacturing/assembly error 3.Use error 4.Incorrect material 5.Solvent bond force incorrect" the reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1)
• 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: 17790230
• MDR Text Key: 323948869
• Report Number: 0002936485-2023-00966
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• 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