MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA CONTROL UNIT, HIGH DEF, 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 72201919

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that during laparoscopy surgery, the screen went blank with each pulse for 2-3 seconds.It is unknown whether there was a back up available or delay in the case.

Event Description

It was reported that during a laparoscopy surgery, the screen went blank with each pulse for 2-3 seconds.The procedure was completed with a competitor device (stryker and storz) and no delay or patient injuries were reported.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: CAMERA CONTROL UNIT, HIGH DEF, 560P
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8363591
• MDR Text Key: 137055512
• Report Number: 1643264-2019-00136
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 03596010643094
• UDI-Public: 03596010643094
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K070266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1