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

Model Number 242018

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4). The device was received and evaluated at the service center. The reported complaint that the scope appears to have a crack as it fogged up was confirmed. The following defects were found with the device upon evaluation : the whole endoscope shows traces of usage (i. E. Scratches). The distal end shows traces of usage (i. E. Discolorations, scratches, dents). There are deposits on the distal cover glass that can partially be removed with acetone and a q-tip. The image on the camera is cloudy. Moisture could be detected inside the optical system of the endoscope. The outer tube of the endoscope is bent. There are deep dents in the outer tube of the endoscope visible. Click noises could be heard by shaking the endoscope. The gluing connection between the last spacer and the optic tube is loosened - field stop defective and loose. Glue residues can be seen. The endoscope is leaking at the distal end. The device was repaired, tested and found to be working according to specifications. The image on the camera does not meet the specifications due to the moisture inside the optical system of the endoscope. The endoscope is leaking at the distal end, which allowed the moisture to reach inside the optical system of the endoscope. The leakage could be caused by microcracks in the soldering seam of the distal end. This damage, the bent outer tube, the dents in the outer tube and the loosened last spacer were caused by too much force being applied on the endoscope by the customer during usage time or by an handling error. Most probably, the endoscope was hit or fell down by mistake. The gluing connection between the last spacer and the optical system is broken, which caused the last spacer to move. Normally, the last spacer is fixing the optical components inside the optical system. But due to the loosened last spacer the optical components inside the optical system just moved around freely. This has caused the clicking noises. The exact circumstances that led to these damages could not be identified. The deposits on the distal cover glass are caused by an improper cleaning of the endoscope by the customer after usage. The service history has been reviewed in lieu of the device history record for this device since it was previously serviced. The device was last serviced on 05/30/2019 and passed all functional testing before being returned to the customer. 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 a shoulder repair procedure on (b)(6) 2020, it was observed that the hd epscp,4. 0,30,167,mitek scope device had a crack as it fogged up. During in-house engineering evaluation, it was determined that there were deposits on the distal cover glass and the image on the camera was cloudy on the device. Another like device was used to complete the case with no delay or patient consequence. No additional information was provided.

• Brand Name: HD EPSCP,4.0,30,167,MITEK
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle MA CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11366681
• MDR Text Key: 234074907
• Report Number: 1221934-2021-00618
• Device Sequence Number: 1
• Product Code: HRX
• 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: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 242018
• Device Catalogue Number: 242018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/23/2021
• 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