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

Catalog Number 0620040610

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/23/2019

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 there was excessive co2 levels in the patient¿s blood.

Event Description

It was reported that there was excessive co2 levels in the patient¿s blood.

Manufacturer Narrative

Based off of previous complaint investigation 2071298, the product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: excessive co2.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.Pressure button does not disengage 7.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge 8.Flow sensor malfunction 9.Ppv failure 10.Manufacturing/ service error the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8683500
• MDR Text Key: 147497091
• Report Number: 0002936485-2019-00232
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 75