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

Catalog Number	0250070600
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the device clogged.
Event or Problem Description
It was reported that the device clogged.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: today i had a customer that is very familiar with our ahto irrigator go through 4 consecutive ahto tubesets because of clogging in the body of the handpiece during suction.The issue was resolved when a different lot number was pulled.The probable root cause could bio burden substance from the use of the instrument port, or normal use.

• Brand Name: STRYKER AHTO TUBE SET PACKAGING
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12418777
• Report Number: 0002936485-2021-00488
• Device Sequence Number: 19850523
• Product Code: GCX
• UDI-Device Identifier: 37613327061490
• UDI-Public: 37613327061490
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042454
• 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): 09/09/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0250070600
• Device Lot Number: 21082FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1