MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1688 AIM 4K AUTOCLAVABLE CAMERA HEAD, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 1688410105

Device Problems Break (1069); Fogging (1253)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was foggy image.

• Brand Name: PKG, 1688 AIM 4K AUTOCLAVABLE CAMERA HEAD, C-MOUNT
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18990025
• MDR Text Key: 338782399
• Report Number: 0002936485-2024-00273
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327562545
• UDI-Public: 07613327562545
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1688410105
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1