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

Model Number 0502990070

Device Problems No Display/Image (1183); Optical Obstruction (3002)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2019

Event Type  malfunction  

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 Description

It was reported that there could be a potential of adverse consequences due to image loss.

Event Description

It was reported that there could be a potential of adverse consequences due to image loss.

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
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9398930
• MDR Text Key: 176096529
• Report Number: 0002936485-2019-00531
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 07613327063998
• UDI-Public: 07613327063998
• Combination Product (y/n): N
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1