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 Suction Problem (2170); Obstruction of Flow (2423)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was clogging during procedure.The procedure was completed successfully.

Manufacturer Narrative

Alleged failure: hi (b)(6) could you help me process a complaint on the below lot number of suction irrigators? 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.This is a high profile customer, and i want to do right by them.Can we replace the current product at the account via out of box failure? lot: 21081fg2.Quantity at account: 24 (4 boxes).Product will be returned for evaluation.Salesforce case number (b)(4) the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could bio burden substance from the use of the instrument port, or normal use.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was clogging 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: 12137326
• MDR Text Key: 262878585
• Report Number: 0002936485-2021-00371
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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: 21081FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1