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 Problems Material Fragmentation (1261); Packaging Problem (3007)

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

Event Date 02/10/2022

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 foreign material was found inside the sterile packaging.

Event Description

It was reported that foreign material was found inside the sterile packaging.

Manufacturer Narrative

Alleged failure: when opened, a piece of plastic was found in sterile packaging.Please see images attached.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be the tyvek cover was dirty or the packages hand had contaminants during packaging.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• 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: 14602081
• MDR Text Key: 294383009
• Report Number: 0002936485-2022-00296
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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