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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,2.7,30,75,CW_STORZ RIGID ENDOSCOPE

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MEDOS INTERNATIONAL SARL HD EPSCP,2.7,30,75,CW_STORZ RIGID ENDOSCOPE Back to Search Results
Model Number 242056
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2021
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Investigation summary
==
> the device was received and evaluated at the service center. The reported complaint that the scope has a crack on the tip of the scope was confirmed. The following defects were found with the device upon evaluation: outer tube damaged. Distal tip damaged, distal tip has deposits. The defective parts were replaced and the device was tested and found to be working according to specifications. User mishandling is the most probable root cause of the damage to the outer tube and improper cleaning / maintenance would have caused the deposits on the distal tip. The damage to the distal tip is most likely a result of user error or mishandling, possibly a contact with a sharp instrument during a surgical process. There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required. At this point in time, no corrective action is required, and no further action is warranted. Depuy 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.
 
Event Description
It was reported by the sales rep that during return inspection, it was observed that the hd epscp,2. 7,30,75,cw_storz device had a crack on the tip of the scope. During in-house engineering evaluation, it was determined that the distal tip on the device had deposits. There was no procedure nor patient involvement. No additional information was provided.
 
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Brand NameHD EPSCP,2.7,30,75,CW_STORZ
Type of DeviceRIGID ENDOSCOPE
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key11361980
MDR Text Key245568018
Report Number1221934-2021-00605
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number242056
Device Catalogue Number242056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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