MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, IDEAL EYES ZOOM COUPLER, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1488020125
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
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 was a blurry image.
Event or Problem Description
It was reported that there was a blurry image.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report is attached (see comm log), and indicates: reported by the customer: not focusing.P/n #: 1488020125.S/n # : (b)(6).Summary of evaluation: unable to replicate fault reported by customer.Focusing ring functions as specified in qip.No faults found.Qip# qip10193 rev.F.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.

• Brand Name: PKG, IDEAL EYES ZOOM COUPLER, C-MOUNT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10871278
• Report Number: 0002936485-2020-00477
• Device Sequence Number: 14075940
• Product Code: GCJ
• UDI-Device Identifier: 07613327061086
• UDI-Public: 07613327061086
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132785
• 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): 01/13/2021

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: 1488020125
• Device Catalogue Number: 1488020125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1