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

Model Number 242018

Device Problems Crack (1135); Poor Quality Image (1408); Failure to Clean Adequately (4048)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (01)10886705029150(21)1381292 investigation summary: the complaint device was received at the service center and evaluated. It was reported that the device was cracked. Per service reports, this complaint can be confirmed. During the service evaluation the following defects were identified: outer tube damaged. Distal tip damaged, shaver damage to distal tip, distal tip has deposits, holes in distal tip fiber. Image error, on camera - image cloudy/blurred. Minor scratches on the unit. The defective parts were replaced to resolve the issues. After repair, the device was found to be working according to the specifications. The faulty parts was identified as the root cause for the device failure during the service evaluation. Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing. 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 an unknown procedure on (b)(6) 2021, it was observed that the hd arthroscope/sinuscope 4. 0mm x 30 deg x 167mm (mitek lock) endoscope device was cracked. During in-house engineering evaluation, it was determined that the distal tip on the device was damaged, had deposits and holes in the distal fiber. It was further determined that the image on the device had error; and was cloudy and blurred. There were no adverse patient consequences nor surgical delay reported. 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 Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13018084
• MDR Text Key: 282630970
• Report Number: 1221934-2021-03766
• 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: Other,Company Representative

Reporter Occupation

• Type of Report: Initial

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/16/2021
• 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: 10/14/2021
• Date Manufacturer Received: 12/15/2021
• 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: Unkown