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

Model Number 0620040600

Device Problems No Flow (2991); Pressure Problem (3012)

Patient Problems Peritoneal Laceration(s) (2003); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

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 case was delayed a few days due to loss of insufflation during procedure.

Event Description

It was reported that the case was delayed a few days due to loss of insufflation during procedure.

Manufacturer Narrative

Alleged failure: cib, levian, rep, calibration or something wrong with the flow, wcb.*update: loss of insufflation for a little during a case until worked for a while and then stopped working properly after case was over.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be third party repair.The unit is also past due for calibration.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: 16792208
• MDR Text Key: 313801410
• Report Number: 0002936485-2023-00337
• Device Sequence Number: 1
• Product Code: HIF
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: 03/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2023
• 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
• Patient Outcome(s): Other