MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,4.0,30,167,MITEK; RIGID ENDOSCOPE

Model Number 242018

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 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the scope was cracked, was confirmed.The following defects were found with the device upon evaluation by the manufacturer: outer tube damaged, distal tip damaged, shaver damage to distal tip, distal tip has deposits, image error, on camera, image cloudy/blurred.The device was diagnosed and repaired using spare parts.It was tested and found to be working according to specifications.User mishandling of the device, probably due to a fall, is the most probable root cause of the physical damages to the device.The distal tip has been damaged due to contact with the shaver during a surgical procedure as identified during evaluation.Also the deposits on the distal tip can be attributed to lack of cleaning and maintenance of the device by the customer.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.Udi: (b)(4).

Event Description

It was reported by affiliate via email that during procedure the hd epscp, 4.0, 30, 167, mitek was cracked.No surgical delay or patient consequence reported.The device is available to be returned for evaluation.Additional information provided by the affiliate reported the failure was noted during pre-operative activities.It was reported the case was completed with another readily available device and surgical intervention is not required.

• Brand Name: HD EPSCP,4.0,30,167,MITEK
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10542297
• MDR Text Key: 207219035
• Report Number: 1221934-2020-02637
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705029150
• UDI-Public: 10886705029150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242018
• Device Catalogue Number: 242018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1