MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK); INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620040690
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was loss of insufflation during surgery due to tubing disconnection.
Additional 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: loss of insufflation.Probable root cause: pressure sensor malfunction / out of calibration; software malfunction; use error; system design; unwanted movement of internal components / wiring; power button inadvertently turned off; tubeset/gas supply inadvertently detached/loose; loss of power; pressure button does not disengage ; electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge; power supply malfunction; flow sensor malfunction; leaks from internal connections or seals; ppv failure; manufacturing/ service error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
Event or Problem Description
It was reported that there was loss of insufflation during surgery due to tubing disconnection.
Additional Manufacturer Narrative
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 november 15th, 2017, as a serious injury, mdr 0002936485-2017-01109.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.
Event or Problem Description
It was reported that there was loss of insufflation during surgery due to tubing disconnection.

• Brand Name: PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK)
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 10886494
• Report Number: 0002936485-2020-00481
• Device Sequence Number: 16948150
• Product Code: HIF
• UDI-Device Identifier: 37613327055659
• UDI-Public: 37613327055659
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2022

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
• Operator of Device: Other
• Device Catalogue Number: 0620040690
• Device Lot Number: 56006282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020; 10/29/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/18/2021; 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown