MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,4.0,70,175,CW_STORZ; RIGID ENDOSCOPE

Model Number	242009
Medical Device Problem Codes	Poor Quality Image (1408); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that during a hip arthroscopy, the distal tip-of the 70 degree scope came in contact with the shaver blade, scratching the distal tip.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the unit, bent/dented, outer tube damaged distal tip damaged, holes/damaged in distal tip fiber, image error on camera image cloudy/blurred, moisture in system.The parts were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The user error was identified as the root cause for the device failure during the service evaluation.Old sn (b)(4) is changed to new sn (b)(4).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 or Problem Description
It was reported by the customer that during an arthroscopic hip surgery on (b)(6) 2021, it was observed that the distal tip-on the hd epscp, (b)(4 )storz endoscope device came in contact with the shaver blade then scratching the distal tip.During in-house engineering evaluation, it was determined that the device had an image error; and that the image on the camera was cloudy/blurred.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: HD EPSCP,4.0,70,175,CW_STORZ
• Common Device Name: 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: 12915903
• Report Number: 1221934-2021-03546
• Device Sequence Number: 20151315
• Product Code: HRX
• UDI-Device Identifier: 10886705028788
• UDI-Public: 10886705028788
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 242009
• Device Catalogue Number: 242009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown