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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL HD LAPSCP,EP,5.5,30,300; RIGID ENDOSCOPE
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MEDOS INTERNATIONAL SàRL HD LAPSCP,EP,5.5,30,300; RIGID ENDOSCOPE Back to Search Results
Model Number 242633
Device Problems Loose or Intermittent Connection (1371); Poor Quality Image (1408)
Patient Problem Not Applicable (3189)
Event Date 11/08/2019
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported by the sales rep that during an arthroscopy procedure, it was observed that the hd laparoscope,ep,5.5mm,30 deg x 300mm, had something loose internally with the scope and the image was impacted.The procedure was completed by rebooting the tower and it eventually worked.There was no patient harm but there was a five minute surgical delay to the case.The sales rep was not present for the case therefore could not provide any further information.There was a delay in the surgical procedure.A spare device was not needed 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.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: a manufacturing record evaluation was performed for the finished device [1313923] number, and no non-conformances were identified.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: correction: d10: the date device returned to manufacturer has been updated to reflect the correct information.Investigation summary : the complaint device was received at the supplier facility and evaluated.The sales rep reported that there was something loose internally with the scope and the image was impacted.Per evaluation findings, this complaint can be confirmed.During evaluation, it was found that the negative lens inside the optical system was loosened and moved around.There were scratches on the endoscope.There were discoloration and scratches at the distal end.The soldering seam at the distal end was also eroded.The image on the camera was cloudy and partially dark.The particles were visible under the distal cover glass.A loosened gluing connection between two optical components, and moisture were detected inside the optical system of the endoscope.The issues were resolved with spare parts, and the device was found to be fully functional after carrying out the repair activities.Due to a change in parts, the serial number was changed from (b)(4) to (b)(4).As per the analysis of the supplier, the loosened gluing connection has caused the negative lens inside the optical system to get loosened, thus it moved around; this caused the image on the camera to be partially dark.The particles which were seen under the distal cover glass were glue residues.This type of damage could be caused by applying too much force on the endoscope by the customer during usage and/or by a hit/fall.The image on the camera was cloudy because of the moisture present inside the optical system of the endoscope.Moisture could get inside the optical system through the leakage at the soldering seam at the distal end.The soldering seam at the distal end could be eroded due to a wrong/too strong reprocessing method used by the customer such as the usage of aggressive disinfectant, or by a high number of reprocessing cycles.The leakage was caused by micro cracks in the soldering seam at the distal end.Excessive force on the endoscope can also lead to micro cracks in he soldering seam.These are the most probable root causes, however, definite root causes of the identified failures cannot be determined with the available information.A manufacturing record evaluation was performed for the finished device serial number (b)(4), and no non-conformances were identified.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.
 
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Brand Name
HD LAPSCP,EP,5.5,30,300
Type of Device
RIGID ENDOSCOPE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9362580
MDR Text Key208322911
Report Number1221934-2019-59699
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10886705030194
UDI-Public10886705030194
Combination Product (y/n)N
PMA/PMN Number
K941541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number242633
Device Catalogue Number242633
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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