MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKER AHTO TUBE SET PACKAGING; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number 0250070600

Device Problem Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was loss of insufflation during procedure.The procedure was completed successfully.

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: material/design error.Constant irrigation flow is not maintained leading to limited field of view.Stopcocks in improper configuration.Large anatomy.Missing o-ring.Damaged or deformed o-ring.Pump malfunction.Clogged tubing.Manufacturing/ service error.User error.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was loss of insufflation during procedure.The procedure was completed successfully.

• Brand Name: STRYKER AHTO TUBE SET PACKAGING
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10843969
• MDR Text Key: 217702927
• Report Number: 0002936485-2020-00463
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 37613327061490
• UDI-Public: 37613327061490
• Combination Product (y/n): N
• PMA/PMN Number: K042454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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: Health Professional
• Device Catalogue Number: 0250070600
• Device Lot Number: 19357FG2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1