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 Increase in Pressure (1491); Pressure Problem (3012)

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

Event Date 03/22/2023

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 overpressure.

Manufacturer Narrative

The device was received at the local service facility for investigation.The technical service report is attached (see comm log), and indicates: ro#: (b)(4).Account: genmed gloucester.Reported by the customer: ref: (b)(4).An error message halfway through surgery saying there was an occlusion with the gas.Surgeon was unable to find the issue with the gas tubing so assume it¿s a fault with the machine.It came up with a red symbol which stopped the gas and stopped us using it.Happened twice last week but resolved itself prior to a repair job being rasied p/n #: 0620040611.S/n: (b)(4).Summary of evaluation: device received out of calibration ¿ calibration on this device was due on 1/6/2021.Successfully completed calibration and qip.Device will be shipped back to the customer.Probable root cause: system design (tolerance stack up issue).Manufacturing / assembly/ service error.Use error.Damage during shipping (inadequate packaging).Damage during shipping (abuse during transit).Tubeset locking mechanism malfunction.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that there was overpressure.

• 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: 16734763
• MDR Text Key: 313294538
• Report Number: 0002936485-2023-00309
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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: Health Professional
• Device Catalogue Number: 0620040611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 11/10/2023
• 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