MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 5.5MM 45, HD BARIATRIC AUTOCLAVABLE LAPAROSCOPE 45CM; SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number	0502513045
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
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 blurry image.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.This scope was not received for evaluation at stryker endoscopy.This scope was received at henke for evaluation.Based on the henke service record attached, the reported failure [cloudy] was confirmed.According to henke: scope evaluated as a level 3.Distal tip and fiber damage, loose optics, bent needle, scratches and residue.The complaint for ¿cloudy lens¿ has been confirmed.Probably root cause for this failure is: due to customer use and handling.The manufacture date is not known.
Event or Problem Description
It was reported that there was a blurry image.

• Brand Name: PRECISION IDEAL EYES 5.5MM 45, HD BARIATRIC AUTOCLAVABLE LAPAROSCOPE 45CM
• Common Device Name: SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11088011
• Report Number: 0002936485-2020-00561
• Device Sequence Number: 3859223
• Product Code: IZH
• UDI-Device Identifier: 07613327059281
• UDI-Public: 07613327059281
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K993045
• 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): 02/16/2021

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: 0502513045
• Device Catalogue Number: 0502513045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1