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	Optical Obstruction (3002)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
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 blurry image during procedure.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report is attached (see communication log), and indicates: problem summary : pi 2675284 advanced exchange - cloudy.Technician notes : external repair passed for shipping.Repair details: pi2675284.Fault reported by the customer: blurry.Faults found: as per reported, poor image quality send to henke for inspection / repair.Probable root cause: incorrectly assembled optical train.Damage to optical train.End of life wear-out.Shipping damage.Use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was blurry image during procedure.

• 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
• MDR Report Key: 11787191
• Report Number: 0002936485-2021-00244
• Device Sequence Number: 13721361
• Product Code: OWN
• UDI-Device Identifier: 07613327063905
• UDI-Public: 07613327063905
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 0502937010
• Device Catalogue Number: 0502937010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1