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

Catalog Number 0250070600

Device Problems Obstruction of Flow (2423); No Flow (2991)

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

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tubing clogged during procedure.The procedure was completed successfully.

Event Description

It was reported that the tubing clogged 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.The reported failure mode will be monitored for future reoccurrence.Alleged failure: clogged.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.Manufacture date is not known.H3 other text : 81.

• 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: 10517745
• MDR Text Key: 207309141
• Report Number: 0002936485-2020-00371
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 2015FG2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1