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

Catalog Number	0620040610
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that there was patient death, no other information was given.
Additional 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.
Additional Manufacturer Narrative
Alleged failure: patient death, no other information was given.The complainant was contacted for further event details and the involvement of the stryker device.The complainant responded that there were no additional event details available and that while the stryker device was in use at time of the event, cause or contribution was unable to be determined at this time.The device was returned for evaluation.Upon visual inspection, the device was received with a calibration sticker showing calibration was past due on (b)(6) 2015.The quality seal is partially torn.A sticker from a third-party company was present indicating an inspection was due on the device in (b)(6) 2024.The chassis was inspected with the following observances noted: the unit was received with a tubeset adapter.The sinter filter on the gas adapter appears saturated with debris.Upon functional inspection, the device was powered on and successfully completed the self check.The review of the error log showed that the self test on the lpu failed several times.The lpu self check occurs when the device is powered on.If the self test fails, the user cannot select an operating screen and the device will not function until the unit is power cycled and the self check passes.Flowrate and pressure tests were preformed, the unit passed each of these tests with no observances and the device performed to specification.The insufflator was then run with a set pressure of 10 mm hg, 20 mm hg, and 30 mm hg while in veress insufflation.The overpressure alarm sounded as intended.The unit was power cycled for 20 complete cycles.There were no errors observed.The safety functions of the device were tested and found to meet specification with no errors observed.As noted, the sinter filter on the gas adapter appeared to be saturated with debris, this could possibly affect the flow rate of co2.This would mean that the time taken for the flow of the insufflator to reach a set pressure could take longer than usual if the sinter filter is obstructed.However, the safety functions of the device were tested and found to meet specification with no errors observed.Additionally, while error logs indicated that the lpu had failed the self test, the device passed all functional criteria and no functional abnormalities were identified.Therefore, the complaint is not confirmed.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.As a specific deficiency or failure of the device was not reported by the account, the specific event could not be confirmed.The device was operating according to specification.Based on the additional information received from the complainant and the investigation results of the returned device, it does not seem likely that the stryker device caused or contributed to the reported event.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was patient death, no other information was given.Multiple attempts for further information were made, how no response was received.

• Brand Name: PKG, PNEUMO SURE XL HG FLW INSUFFLATOR
• Common Device Name: 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20972868
• Report Number: 0002936485-2024-00967
• Device Sequence Number: 8361895
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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
• Operator of Device: Other
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 118 KG