MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 5MM 0A LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0502539010
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was foggy image.
Additional Manufacturer Narrative
Alleged failure: foggy confirmed failure: outer tube damaged (bent, dented),moisture ingression at distal end,moisture ingression at proximal end,broken rod lens.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 product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The manufacture date is not known.
Event or Problem Description
It was reported that there was foggy image.

• Brand Name: HD 5MM 0A LAPAROSCOPE, AC
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11843382
• Report Number: 0002936485-2021-00262
• Device Sequence Number: 4395721
• Product Code: GCJ
• UDI-Device Identifier: 07613327059403
• UDI-Public: 07613327059403
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K910132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0502539010
• Device Catalogue Number: 0502539010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1