MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040660

Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

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 tubing connection detached which can potentially lead to loss of insufflation.

Event Description

It was reported that the tubing connection detached which can potentially lead to loss of insufflation.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: connection issue probable root cause: 1.Software malfunction 2.Power supply malfunction 3.Insufflator design 4.Unwanted movement of internal components / wiring 5.Use error 6.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge 7.Mio board malfunction 8.Bam board malfunction 9.Lcd assembly failure 10.Manufacturing/ service error the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.Please note we are discontinuing the current practice of filing malfunction medical device reports (mdrs) for reported complaints related to tubing disconnection on pneumosure tubesets.The initial event of this failure was filed on (b)(6) 2017, as a serious injury, mdr (b)(4).This malfunction has not caused or contributed to any further deaths or serious injuries for two years.Therefore, we will discontinue filing mdrs for pneumosure tubesets due to potential loss of insufflation during surgery due to tubing disconnection.This will be the last filing related to tubing disconnection on tubesets for pneumosure.H3 other text : 81.

• Brand Name: PKG; HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK)
• 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: 15477959
• MDR Text Key: 306262560
• Report Number: 0002936485-2022-00538
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 37613327055635
• UDI-Public: 37613327055635
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040660
• Device Lot Number: 22F0170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1