MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA HEAD HD 1200 AUTOCLAVABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72203360
Medical Device Problem Codes	No Display/Image (1183); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery the device shut down during surgery.A backup device was used to complete the surgery.No delay or patient injury reported.
Additional Manufacturer Narrative
Device evaluated by mfr: an evaluation was performed by smith and nephew and could not confirm the customer complaint for it shut down during surgery.A visual inspection was performed and showed no damage to the camera head.Functional inspection was performed and showed when the camera head was connected to the camera system there was a clear sharp image on the monitor.No manufacturing related defects were observed.

• Brand Name: CAMERA HEAD HD 1200 AUTOCLAVABLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8957891
• Report Number: 3003604053-2019-00115
• Device Sequence Number: 19370844
• Product Code: GCJ
• UDI-Device Identifier: 03596010657497
• UDI-Public: 03596010657497
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K014158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 72203360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1