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

Catalog Number 0620040660

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was foreign material inside of the sterile packaging.

Event Description

It was reported that there was foreign material inside of the sterile packaging.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: hair found in package.Probable root cause: system design.Assembly error.Use error.Component non-conformance.The device manufacture date is not known.

• 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
• MDR Report Key: 7862057
• MDR Text Key: 119830939
• Report Number: 0002936485-2018-00600
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 37613327055635
• UDI-Public: 37613327055635
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

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: 0620040660
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1