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 Puncture/Hole (1504)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer 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 a piece of the piercing membrane fell inside the patient.Please note that the piece was removed and 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: a piece of the piercing membrane was rinsed into the rinsing solution probable root cause: 1.Material/design error.2.Manufacturing/assembly/ service error.3.Excessive user force.4.Severe shipping conditions.5.Disposable tip rubbing against product.6.User error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that a piece of the piercing membrane fell inside the patient.Please note that the piece 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12816788
• MDR Text Key: 281905045
• Report Number: 0002936485-2021-00628
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 37613327061650
• UDI-Public: 37613327061650
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K042454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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: 0250070620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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