MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., HIGH FLOW INSUFFLATION TUBE SET; TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC

Catalog Number	0620030301
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there was foreign material inside the sterile packaging.
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: not sterile.Probable root cause: 1.System design (tolerance stack up issue) 2.Manufacturing / assembly/ service error.3.Use error.4.Damage during shipping (inadequate packaging).5.Damage during shipping (abuse during transit).6.Gas connector cross threading.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that there was foreign material inside the sterile packaging.

• Brand Name: PKG., HIGH FLOW INSUFFLATION TUBE SET
• Common Device Name: TUBING/TUBING WITH FILTER, INSUFFLATION, 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: 16728574
• Report Number: 0002936485-2023-00298
• Device Sequence Number: 17804009
• Product Code: NKC
• UDI-Device Identifier: 37613327055604
• UDI-Public: 37613327055604
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K983566
• 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
• Report Date (Section B): 09/25/2023

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: 0620030301
• Device Lot Number: 22217FE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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