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

Catalog Number 0620040614

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the case was rescheduled to a different hospital.

Event Description

It was reported that the case was rescheduled to a different hospital.

Manufacturer Narrative

The device was received at the local service facility for investigation.The technical service report indicates: "high pressure valve leakage, low pressure unit calibration error.Replace high pressure valve and low pressure unit".Probable root cause: - pressure sensor malfunction / out of calibration - software malfunction - use error - system design - unwanted movement of internal components / wiring - power button inadvertently turned off - tubeset/gas supply inadvertently detached/loose - loss of power - pressure button does not disengage - electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge - power supply malfunction - flow sensor malfunction - leaks from internal connections or seals - ppv failure - manufacturing/ service error.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W/ SIDNE (ASIA)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8593168
• MDR Text Key: 144551795
• Report Number: 0002936485-2019-00198
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0620040614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1