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

Catalog Number 0250070620

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: a metal piece was washed out of the suction tube into the patient probable root cause: material/design error, manufacturing/assembly error, improper cleaning/sterilization , excessive user force, severe shipping conditions, user misuse.(b)(4).

Event Description

It was reported that a peice of the device entered the patient.The peice was removed and the procedure was completed successfully.

• Brand Name: STRYKER AHTO TUBE SET WITH TIP 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: sandhya jaishankar ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6896417
• MDR Text Key: 87613280
• Report Number: 0002936485-2017-00905
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250070620
• Device Lot Number: 17139FG2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1