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

Model Number	0220220000
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
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 the user was shocked.Please note, it was confirmed that there were no adverse consequences and no medical intervention required.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: customer was shocked when camera cord and light cord were pulled out at the same time, visual inspection: there were no external observances.The manufacturer's warranty seal is intact.Functional inspection: the unit functioned properly with no observances.A known, functional light cable was used alongside the complaint unit.White light was present and the light intensity was able to adjust accordingly.The light cable was pulled out with the light source responding appropriately with no observances.The precision light source unit was tested along with the 1488 camera control unit (s/n: (b)(6), that was sent in as a complaint with the light source.Different, known, functional camera heads, couplers, light cables, scopes, and accessories were also included in the testing at different locations.No issues were observed or felt when the camera heads were unplugged along with the light cables, from the light source and ccu.The light source was tested for proper grounding and the unit passed both the hi- pot and biotech tests (see attached test report).It is difficult to determine the root cause of the issue observed at the account since we are unable to replicate the problem in-house.Possible root causes could be electrical static discharge.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the user was shocked.Please note, it was confirmed that there were no adverse consequences and no medical intervention required.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: hannah stalnaker ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12824741
• Report Number: 0002936485-2021-00632
• Device Sequence Number: 13891001
• Product Code: FCW
• UDI-Device Identifier: 07613327051322
• UDI-Public: 07613327051322
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown