MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 5.5MM 45°, HD AUTOCLAVABLE LAPAROSCOPE 30CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 0502503045

Device Problems Fogging (1253); Poor Quality Image (1408)

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

Event Date 11/02/2022

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 there was foggy image during the procedure.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: foggy confirmed failure: outer tube damaged (bent, dented) loose prism damaged distal cover glass probable root cause: laser welding seal failure distal/proximal window solder failure damage to optical train damage to needle damage to distal or proximal windows moisture intrusion end of life wear-out environmental disturbance: endoscope colder than dew point environmental disturbance: fluid entrapment between the coupler and eyepiece junction (eyepiece only) use error the device manufacture date is not known.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported there was foggy image during the procedure.

• Brand Name: PRECISION IDEAL EYES 5.5MM 45°, HD AUTOCLAVABLE LAPAROSCOPE 30CM
• 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: 15858929
• MDR Text Key: 306545920
• Report Number: 0002936485-2022-00700
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327059175
• UDI-Public: 07613327059175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502503045
• Device Catalogue Number: 0502503045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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