MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., SUCTION / IRRIGATOR 2; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0250070500

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2023

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 there was foreign material inside the sterile packaging.

Manufacturer Narrative

Alleged failure: black foreign material inside sterile packaging salesforce case number 12641648 the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be the was dirty or the packagers hand had contaminants during packaging.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

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

• Brand Name: PKG., ASSY., SUCTION / IRRIGATOR 2
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 16820286
• MDR Text Key: 314085432
• Report Number: 0002936485-2023-00346
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070500
• Device Lot Number: 22206FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2023
• 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