MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM X 0°, 33CM; CONFOCAL OPTICAL IMAGING

Model Number	0502937010
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2023
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: 0502-937-010 aim scope (10mm0°) was delivered and given to line medical(dealer) and delivered to chungnam university hospital on the date mentioned above.The package was opened and sterilized following ¿stryker¿s sterilization instruction¿ on the date.During the installation, we found out the output image from the scope was too foggy to operate properly.We gave our own demo scope (same product), and tested with same sterilization.There was no fogging with our own scope.So, the brand-new scope was returned.We consider this case as ¿out of box failure,¿ because the same product that went through same sterilization had no problem.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be rough handling during sterilization and/or product transport.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was foggy image.

• Brand Name: AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM X 0°, 33CM
• Common Device Name: CONFOCAL OPTICAL IMAGING
• 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: 16616400
• Report Number: 0002936485-2023-00237
• Device Sequence Number: 20047371
• Product Code: OWN
• UDI-Device Identifier: 07613327063905
• UDI-Public: 07613327063905
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: 0502937010
• Device Catalogue Number: 0502937010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2023
• Supplement Date Received by Manufacturer: 02/26/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown