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 Improper or Incorrect Procedure or Method (2017)

Patient Problems Inflammation (1932); Pain (1994); Foreign Body In Patient (2687)

Event Date 06/14/2017

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that a packaging component was left inside the patient.Due to user error, the cap was not removed prior to use.Patient experienced pain and inflammation.

Manufacturer Narrative

(b)(4).Alleged failure: packaging component left inside patient.Probable root cause: material/design error, manufacturing/assembly error, improper cleaning/sterilization, excessive user force, severe shipping conditions, disposable tip rubbing against product, user misuse.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that a packaging component was left inside the patient.Due to user error, the cap was not removed prior to use.Patient experienced pain and inflammation.

• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6723526
• MDR Text Key: 80378751
• Report Number: 0002936485-2017-00691
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• PMA/PMN Number: K042454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/20/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 06/20/2017
• Supplement Dates FDA Received: 01/04/2018
• 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