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

Model Number 0620040600

Device Problems Increase in Pressure (1491); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Electrolyte Imbalance (2196); Low Oxygen Saturation (2477); Chemical Exposure (2570)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer 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 the patient experienced excessive co2 levels.

Manufacturer Narrative

Alleged failure: hard time reading pressure accurately/ may have over pressured.Rep thinks adapter may have issues as well.Salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The root cause is a missing o-ring on the tubeset adapter which was connected to the complaint unit.The missing o-ring can cause pressure and flow fluctuations.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that the patient experienced excessive co2 levels.

• Brand Name: PKG; PNEUMO SURE HIGH FLOW INSUFFLATOR
• 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: 12636594
• MDR Text Key: 276557197
• Report Number: 0002936485-2021-00550
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327063219
• UDI-Public: 07613327063219
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0620040600
• Device Catalogue Number: 0620040600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2021
• 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
• Patient Outcome(s): Other
• Patient Sex: Female