MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD LAPSCP,EP,5.5,0,300; RIGID ENDOSCOPE

Model Number 242632

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (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 by the sales rep that during a shoulder repair procedure, it was observed that the hd laparoscope,ep,5.5mm,0 deg x 300mm had a dot in the center and could not be removed.Another device was used to complete the procedure.No patient consequences or surgical delay reported.No additional information was provided.

Manufacturer Narrative

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: correction: d4: the serial number was inadvertently missed on the initial report.The field has been updated accordingly to reflect the information.Investigation summary : the device was received and evaluated at the service center.The reported complaint that the device had a big dot in the center and could not be removed.The following defects were found with the device upon evaluation : -outer tube damaged, distal tip has deposits.-optical system, optical components negative compact objective loose.The damaged parts were replaced and the device was tested and found to be working according to specifications.User mishandling is the most probable root cause of the physical damage to the outer tube of the device, including the loose objective, the deposits on the distal tip is a result of improper cleaning and maintenance activities by the customer on the device.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.

• Brand Name: HD LAPSCP,EP,5.5,0,300
• 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: 10246748
• MDR Text Key: 198510926
• Report Number: 1221934-2020-01780
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10886705030187
• UDI-Public: 10886705030187
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242632
• Device Catalogue Number: 242632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Date Manufacturer Received: 09/18/2020
• Patient Sequence Number: 1