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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION 1688; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER CORPORATION 1688; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Event Description
No functionality with 1688 endoscope video camera for knee arthroscopy.Two cameras used and surgeon found no functionality with both cameras.Surgery was rescheduled.At the time, staff were unaware of eight additional backup endoscope video cameras to use ¿ all eight cameras were later tested nd found to work by the manufacturer representative.Defective cameras were sent back to the company and replaced with new cameras.The manufacturer representative found the two camera and couplers not working were related to internal camera.
 
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Brand Name
1688
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER CORPORATION
3800 e. centre ave
portage MI 49002
MDR Report Key15731344
MDR Text Key303051199
Report Number15731344
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/14/2022
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/14/2022
Event Location Hospital
Date Report to Manufacturer11/04/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/04/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age28105 DA
Patient SexMale
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