MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA HEAD NON-AC HD560H; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72200561

Device Problem Optical Problem (3001)

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

Event Date 05/15/2020

Event Type  malfunction  

Event Description

It was reported that during the set up the camera head screen was blank, the white balance options were showing in the screen and no image could be seen.No injuries or significant delay reported.It is unknown how the surgery was completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

The reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation did not reveal any problems.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: CAMERA HEAD NON-AC HD560H
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10151450
• MDR Text Key: 195101330
• Report Number: 1643264-2020-00355
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 03596010591104
• UDI-Public: 03596010591104
• Combination Product (y/n): N
• PMA/PMN Number: K070266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

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
• Device Operator: Health Professional
• Device Model Number: 72200561
• Device Catalogue Number: 72200561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Distributor Facility Aware Date: 05/25/2020
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/14/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 04/09/2021
• Supplement Dates FDA Received: 07/17/2020; 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1