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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US 1392 5.9MM STRYKER SHEATH 2 WAY -NS RIGID ENDOSCOPE SHEATH

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DEPUY MITEK LLC US 1392 5.9MM STRYKER SHEATH 2 WAY -NS RIGID ENDOSCOPE SHEATH Back to Search Results
Model Number 281392
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2018
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation. This complaint cannot be confirmed. No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. If any additional information is obtained, this complaint will be re-opened to capture that information. At this point in time, no corrective action is required, and no further action is warranted. However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
 
Event Description
This is report 1 of 2 for the same event. It was reported by the sales rep that two of the customer's stryker scope sheath had cracked o rings and were leaking during a knee scope. The case was completed with the same devices. There were no patient consequences or delays. The sales rep was not present during the case and could not provide any more details. There was no delay in the surgical procedure. It was not reported if a spare device available for use to complete the surgery. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand Name1392 5.9MM STRYKER SHEATH 2 WAY -NS
Type of DeviceRIGID ENDOSCOPE SHEATH
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key9036263
MDR Text Key191004751
Report Number1221934-2019-58299
Device Sequence Number1
Product Code HNX
UDI-Device Identifier10886705016099
UDI-Public10886705016099
Combination Product (y/n)N
PMA/PMN Number
K951702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number281392
Device Catalogue Number281392
Device Lot Number61918018
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2021
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 Unkown

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