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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 07/19/2018
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). Investigation summary: despite multiple attempts made to the sales representative for the return of the complaint device, the device has not been received for evaluation. No further information regarding the cause of the defect has been provided to help determine a root cause for this failure. This complaint cannot be confirmed. No further information regarding the cause of the defect has been provided to help determine a definitive root cause for this failure. This complaint can be confirmed. 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
It was reported by the sales rep via phone that during a shoulder repair procedure the customer's 5. 9 mm stryker sheath 2-way was leaking due to damaged o-rings. The procedure was able to be completed with the device with no harm to the patient or delays to the case. The sales rep was not present for the case therefore could not any further information. There was no delay in the surgical procedure. There was 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 Key9117750
MDR Text Key160045612
Report Number1221934-2019-58504
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 07/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number281392
Device Catalogue Number281392
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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