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

Catalog Number	0240030971
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was an injury to the patients bile duct.
Additional Manufacturer Narrative
Alleged failure: during a laparoscopy, customer was using wise wireless transmitter to carry signal to two wise monitors and both monitors went pixelated with a green hue.To address the issue, a tech hardwired to one monitor to regain signal integrity.There was a bile duct injury reported during the case, but it is unclear if this was caused by the malfunction of the wise transmitter or if this even occurred while the monitors were down.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be transmitter failure.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 an injury to the patients bile duct.

• Brand Name: PKG, WHDTV 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: 8812780
• Report Number: 0002936485-2019-00302
• Device Sequence Number: 2196690
• Product Code: GCJ
• UDI-Device Identifier: 07613327056037
• UDI-Public: 07613327056037
• Combination Product (Y/N): N
• 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): 10/03/2019

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 Catalogue Number: 0240030971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other