MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, SYNK WIRELESS TRANSMITTER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0240031010
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
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
Alleged failure: cib (b)(4), rep.Doesnt always transmit.Sjc0014986.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be (1) interference with other equipment (2) defective token used or (3) issue with the monitor.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was loss of image.

• Brand Name: PKG, SYNK WIRELESS TRANSMITTER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11816842
• Report Number: 3012345110-2021-00004
• Device Sequence Number: 13774199
• Product Code: GCJ
• UDI-Device Identifier: 07613327056075
• UDI-Public: 07613327056075
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081995
• 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): 07/16/2021

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: 0240031010
• Device Catalogue Number: 0240031010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1