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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2020
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 image loss of more than a minute during procedure.Please note that the procedure was completed successfully with no reports of adverse consequences.
Event or Problem Description
It was reported that there was image loss of more than a minute during procedure.Please note that the procedure was completed successfully with no reports of adverse consequences.
Additional Manufacturer Narrative
Alleged failure: this is from an order from 2018, however, equipment was recently installed.Two new transmitters were at the account- one worked and one did not.Sn 18d556034 turns on but does not send signal to monitors.This was noticed in first case- no pt harm or delay.Salesforce case number (b)(4).Update: happened several times on 3-23 to present.Did happen during procedures: yes.List long enough to reboot and try to get signal again.Multiple times daily.Loss for more like a min at a time.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be: interference with other equipment, defective token used or issue with the monitor.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: 9984209
• Report Number: 0002936485-2020-00172
• Device Sequence Number: 3675848
• Product Code: GCJ
• UDI-Device Identifier: 07613327056075
• UDI-Public: 07613327056075
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/29/2020

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: 0240031010
• Device Catalogue Number: 0240031010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1