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

Catalog Number	0220220000I
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
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 image.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: cold light source switched off.Probable root cause: ¿ cables ¿ connectors ¿ digital board ¿ power supply ¿ filter / fuse ¿ ac inlet board ¿ main board ¿ transition board ¿ fiber board ¿ intermittence between transition board and ch connector ¿ software ¿scope ¿light source ¿ camera head ¿ coupler ¿ 1488 & 1588 extension cable ¿ intermittence while using rf devices ¿ problem toggling light source or from camera head ¿ connected monitors ¿ leaking ¿ use error ¿ poor grounding ¿ electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge ¿ manufacturing/ service nonconformity.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was loss of image.

• Brand Name: PKG, PRECISION LED LIGHT SOURCE - INTERNATIONAL KIT
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8573544
• Report Number: 0002936485-2019-00172
• Device Sequence Number: 2346035
• Product Code: FCW
• UDI-Device Identifier: 07613327051322
• UDI-Public: 07613327051322
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/15/2019

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 Catalogue Number: 0220220000I
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1