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

Model Number 72200561

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

It was reported there was no image on the monitor when the camera head was connected.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.A relationship, if any, between the subject device and the reported event could not be determined.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: CAMERA HEAD NON-AC HD560H
• Type of Device: ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10694738
• MDR Text Key: 211929785
• Report Number: 1643264-2020-01555
• Device Sequence Number: 1
• Product Code: GCL
• 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
• Report Date: 11/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 72200561
• Device Catalogue Number: 72200561
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/18/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1