MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION LED LIGHT SOURCE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0220220000
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was loss of light (image) during a procedure.Please note, the procedure was completed successfully.
Event or Problem Description
It was reported that there was loss of light (image) during a procedure.Please note, the procedure was completed successfully.
Additional Manufacturer Narrative
The investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: the customer reported that they had used the light source all day and then during a case the light source just switched off.The surgeon lost visibility, surgeon had to de-gown, a new stack had to be brought into the case and there was surgical delay of 20 minutes.No adverse events or injuries as a result the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be a light cable with a bad reed switch.No problem found with the light source.No light cable was returned for investigation.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, PRECISION LED LIGHT SOURCE
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9520593
• Report Number: 0002936485-2019-00596
• Device Sequence Number: 2756682
• Product Code: FCW
• UDI-Device Identifier: 07613327051322
• UDI-Public: 07613327051322
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 0220220000
• Device Catalogue Number: 0220220000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1