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  

Event Description

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

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.

Manufacturer Narrative

Alleged failure: the last several boxes they ordered of 620-040-660 seem to all have the same problem.The tube set will connect to the insufflator, but within a few minutes if there is the slightest movement on the tubing, it will disconnect and the insufflator stops.They¿ve tried different lot numbers and tried it on every insufflator they own, but the same thing happens every time.Salesforce case number (b)(4).Notes from 9/12/22 no pt harm case completed successfully lot # 22f0170 rma 12122373 the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be a damaged console was used, user excessive force, extreme shipping or storage conditions.The product was returned for investigation and the 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 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 Description

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

• 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: 15478656
• MDR Text Key: 306199091
• Report Number: 0002936485-2022-00539
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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