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

Catalog Number	0620040660
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tubing has broken connection potentially leading to a loss of insufflation.
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: insufflation tubing are coming with broken connections.Probable root cause: manufacturing/ service/ assembly error.Damage during shipment.Damage during shipment.Use error.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that the tubing has broken connection potentially leading to a loss of insufflation.

• Brand Name: PKG; HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK)
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9880463
• Report Number: 0002936485-2020-00139
• Device Sequence Number: 2561059
• Product Code: HIF
• UDI-Device Identifier: 37613327055635
• UDI-Public: 37613327055635
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 0620040660
• Device Lot Number: 19D0162
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1