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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA HEAD LENS INT SYS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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SMITH & NEPHEW, INC. CAMERA HEAD LENS INT SYS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 72203967
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2022
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, during an arthroscopy, the camera head was getting more heated than normal temperature.Surgery was resumed after a delay greater than 30 minutes, using a back-up device instead.No further complications were reported.
 
Manufacturer Narrative
H6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was not confirmed.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a failed control board.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
 
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Brand Name
CAMERA HEAD LENS INT SYS
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key15536687
MDR Text Key301115974
Report Number1643264-2022-00352
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00885556629833
UDI-Public00885556629833
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K153606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/09/2022
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 Number72203967
Device Catalogue Number72203967
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2022
Initial Date FDA Received10/04/2022
Supplement Dates Manufacturer Received12/08/2022
Supplement Dates FDA Received12/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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