MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	0502990070
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
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 could be a potential of adverse consequences due to image loss.
Event or Problem Description
It was reported that there could be a potential of adverse consequences due to image loss.
Additional Manufacturer Narrative
Alleged failure: can not see through scope.Confirmed failure: fiber/cone damage at sidearm,outer tube damaged (bent, dented),broken rod lens,loose prism.Probable root cause: ¿ improper cleaning process at assembly; ¿ loss of in-joint pressure (arthroscopes only); ¿ loss of insufflation (laparoscopes only); ¿ shipping damage; ¿ use error.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG, CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9398930
• Report Number: 0002936485-2019-00531
• Device Sequence Number: 2922735
• Product Code: HIH
• UDI-Device Identifier: 07613327063998
• UDI-Public: 07613327063998
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 0502990070
• Device Catalogue Number: 0502990070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1