MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIM HD LAPAROSCOPE, AUTOCLAVABLE, 5.4MM X 30, 30CM; CONFOCAL OPTICAL IMAGING

Model Number	0502537030
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2020
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 a poor image.
Additional Manufacturer Narrative
Alleged failure: blurry and dark?: (b)(6) the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as the scope did not have any functional observances with the quality of the image.There are cosmetic observances throughout the scope however, there was no blurry and dark image observed as per the customer's complaint.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 a poor image.

• Brand Name: AIM HD LAPAROSCOPE, AUTOCLAVABLE, 5.4MM X 30, 30CM
• Common Device Name: CONFOCAL OPTICAL IMAGING
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10273245
• Report Number: 0002936485-2020-00271
• Device Sequence Number: 3358871
• Product Code: OWN
• UDI-Device Identifier: 07613327059373
• UDI-Public: 07613327059373
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: 0502537030
• Device Catalogue Number: 0502537030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1