MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD LAPSCP,EP,5.5,30,300; RIGID ENDOSCOPE

Model Number 242633

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during quality inspection of the endoscope device, it was observed that it was cloudy.This event did not occur during surgery.There was no 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

Product complaint # (b)(4).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: investigation summary
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> the device was received and evaluated at the service center.The reported complaint that the scope was cloudy, was confirmed.The following defects were found with the device upon evaluation : -outer tube damaged, distal tip damaged -optical system, optical components negative compact objective loose broken lenses in optical system - less than 50% of lenses defective.The device was diagnosed and the failures were resolved using spare parts.The device was tested and found to be working according to specifications.User mishandling or a probable fall are the most probable root causes of the physical damage to the various parts.The damaged components would have caused the device to not function as intended by the customer.A manufacturing record evaluation was performed for the finished device [serial number : (b)(6).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).

• Brand Name: HD LAPSCP,EP,5.5,30,300
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 10521491
• MDR Text Key: 207791000
• Report Number: 1221934-2020-02548
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10886705030194
• UDI-Public: 10886705030194
• Combination Product (y/n): N
• PMA/PMN Number: K941541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242633
• Device Catalogue Number: 242633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1