MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,4.0,70,167,MITEK; RIGID ENDOSCOPE

Model Number	242021
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.There was no allegation of malfunction against the device from the customer, defects were identified during service evaluation.It was found that the scopes were corroded.The device was scrapped, and was found to be non-repairable during evaluation.Fluid ingress into the device would have caused the corrosion in the scope.There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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 affiliate in (b)(6) that preoperatively to unknown surgery on an unknown date, it was observed that the endoscope device had corrosion.During in-house engineering evaluation, it was determined that the scopes were corroded.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: HD EPSCP,4.0,70,167,MITEK
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11628090
• Report Number: 1221934-2021-01125
• Device Sequence Number: 16963895
• Product Code: HRX
• UDI-Device Identifier: 10886705028986
• UDI-Public: 10886705028986
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 242021
• Device Catalogue Number: 242021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1