MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL 3RD EDITION 660IMS; ACCESSORIES,ARTHROSCOPIC

Model Number	72200242S3E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device shut down, causing loss of visualization during surgery.No patient injury reported.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of shutting down by itself could not be reproduced.Unit passed functional testing during 6 hour burn-in including capture and print function.Unit did not shut down during burn-in.All video inputs/outputs normal and unit's display performed as expected.Both analog and digital video outputs were tested during burn-in.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 product did not meet manufacturing specification or would not be able to perform as intended.
Additional 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.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: SVCE REPL 3RD EDITION 660IMS
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7653367
• Report Number: 1643264-2018-00510
• Device Sequence Number: 2012145
• Product Code: NBH
• UDI-Device Identifier: 00885554030846
• UDI-Public: (01)00885554030846
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2018

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: 72200242S3E
• Device Catalogue Number: 72200242S3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/12/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/09/2018; 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1