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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA CAMERA COVER ADAPTOR FOR STRYKER VISIUM LED
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ASPEN SURGICAL PRODUCTS, CALEDONIA CAMERA COVER ADAPTOR FOR STRYKER VISIUM LED Back to Search Results
Model Number LT-9905
Device Problem Component Incompatible (1108)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2018
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.
 
Event Description
Aspen surgical received a report from the end user indicating that a camera cover adaptor is too large/long causing sterile breech issues.The item was in use and no injury/death was reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
Aspen surgical received a report from the customer that the adapter is too large/long and drops down from the light in a way that is causing the surgeons to miss the lip/flange on the cover and inadvertently grab the adapter during surgery causing them to breech the sterile field.The actual device was determined to not be available for evaluation and no lot number was provided.A photo of the device was available.Dhr review could not be performed due to no lot number provided.A picture was provided by the customer.After review of the picture, it was discovered the adaptor shown is not the correct adaptor for lt-9905.Based on this review, the adaptor for lt-9905 should have been 3660-str and according to the picture that is not the adaptor.Therefore, this complaint cannot be confirmed.Based on this information, no further action is required.
 
Event Description
Aspen surgical received a report from the end user indicating that a camera cover adaptor is too large/long causing sterile breech issues.The item was in use and no injury/death was reported.This report was filed in our complaint handling system as (b)(4).
 
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Brand Name
CAMERA COVER ADAPTOR FOR STRYKER VISIUM LED
Type of Device
CAMERA COVER ADAPTOR
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
MDR Report Key7285909
MDR Text Key100902746
Report Number1836161-2018-00016
Device Sequence Number1
Product Code FTA
Combination Product (y/n)N
PMA/PMN Number
K020304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLT-9905
Was Device Available for Evaluation? No
Date Manufacturer Received01/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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