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

Model Number	0240031010
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
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.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: not sending and holding signal probable root cause: ¿ token ¿ token slot ¿ wireless interference /available channels ¿ tx main/front/antenna board ¿ display main/antenna board ¿ transmitter mac/software ¿ display firmware / silex/ application software ¿ use error ¿ electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge ¿ manufacturing/ service nonconformity.
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.

• 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: 9983374
• Report Number: 0002936485-2020-00167
• Device Sequence Number: 4442708
• 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): 06/18/2020

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?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1