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

Catalog Number 0620040610

Device Problem Increase in Pressure (1491)

Patient Problem No Information (3190)

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.Mfr date: 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 overpressure was experienced.

Manufacturer Narrative

Alleged failure: eib jamale onsite overpressure.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint, as there were no overpressure issues observed during the testing of the insufflator.However, the insufflator was past due for calibration and the current high pressure unit inside the insufflator is outdated.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that overpressure was experienced.

• 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
• 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: 7936262
• MDR Text Key: 122814417
• Report Number: 0002936485-2018-00634
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• 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: 07/11/2019

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: Other
• Device Catalogue Number: 0620040610
• Device Lot Number: 1202CE202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 07/11/2019
• 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