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

Catalog Number 0620040611

Device Problems No Pressure (2994); Output Problem (3005)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that there was loss of insufflation during procedure.

Manufacturer Narrative

The device was not received for investigation at stryker endoscopy because it was repaired locally in stryker united kingdom reported by the customer: pi using a lot of gas, maybe a lead p/n #: 0620040611.S/n: (b)(6).Summary of evaluation: touch screen / mio board issue, device failed to boot up / touch screen.Inactive, unable to confirm reported defect due to device not booting up correctly".Probable root cause: 1.Pressure sensor malfunction / out of calibration.2.Software malfunction.3.Use error.4.System design.5.Unwanted movement of internal components / wiring 6.Power button inadvertently turned off.7.Tubeset/gas supply inadvertently detached/loose.8.Loss of power.9.Pressure button does not disengage.10.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.11.Hpu or lpu assembly malfunction.12.Leaks from internal connections or seals.13.Ppv failure.14.Manufacturing/ service error.Furthermore, reportability decision was checked for consistency.Manufacture date is not known.

Event Description

It was reported that there was loss of insufflation during procedure.

• 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: 16464169
• MDR Text Key: 310497455
• Report Number: 0002936485-2023-00183
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• 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: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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