MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,4.0,30,175,CW_STORZ; RIGID ENDOSCOPE

Model Number 242006

Device Problems Poor Quality Image (1408); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Initial reporter phone number: (b)(6).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had stains and scratches on it, was confirmed.It was found that the device was dirty and produced a bad image.Further, the light post, optics and the distal tip were found to be damaged and the shaft was bent.The damaged components of the device were replaced and the device was cleaned, tested and found to be fully functional.User mishandling and lack of maintenance of the device is responsible for the physical damage to the device and the presence of stains on the device.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.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.Udi: (b)(4).

Event Description

It was reported by affiliate via email that a hd ep arthroscope/sinuscope 4.0 mm x 30 deg x 175 mm (storz lock) presented stains and scratches.No surgical delay or patient consequence reported.No further information available.

• Brand Name: HD EPSCP,4.0,30,175,CW_STORZ
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9988026
• MDR Text Key: 204559697
• Report Number: 1221934-2020-01225
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705028740
• UDI-Public: 10886705028740
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242006
• Device Catalogue Number: 242006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1