MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1588 AIM CAMERA HEAD WITH INTEGRATED COUPLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1588610122
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
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 a blurry image during a procedure.Please note, the procedure was completed successfully.
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: intermittent light loss (flickering) noticed during a case 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 (dust on optics, scratched optics, broken / shifted lenses, focusing mechanism, endoclamp, zoom ring) 1488 & 1588 extension cable intermittence while using rf devices problem toggling light source or from camera head connected monitors leaking use error poor grounding (e.G."finger" grounding tab connecting front and rear enclosure.Camera head connection from cable to transition board.) 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 a blurry image during a procedure.Please note, the procedure was completed successfully.

• Brand Name: PKG, 1588 AIM CAMERA HEAD WITH INTEGRATED COUPLER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9765810
• Report Number: 0002936485-2020-00092
• Device Sequence Number: 11580253
• Product Code: GCJ
• UDI-Device Identifier: 07613327174380
• UDI-Public: 07613327174380
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K132785
• 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): 04/30/2020

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: 1588610122
• Device Catalogue Number: 1588610122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1