MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 660 HD IMS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72200242
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an acl reconstruction, when turning the image management system on, the windows app did not load.The operation was performed without the device, since there was not a back-up device available.The surgery was delayed for less than 30 min.The patient was not injured.
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 boot up malfunction could not be reproduced.Unit passed functional testing during 6 hour burn-in including capture and print function.Unit also passed power cycling test.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.

• Brand Name: 660 HD IMS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8915195
• Report Number: 1643264-2019-00554
• Device Sequence Number: 1746565
• Product Code: GCJ
• UDI-Device Identifier: 03596010566676
• UDI-Public: 03596010566676
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K060777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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 Catalogue Number: 72200242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1