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

Model Number 242021

Device Problem Degraded (1153)

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

Event Type  malfunction  

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 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
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle MA CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11628090
• MDR Text Key: 245110240
• Report Number: 1221934-2021-01125
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705028986
• UDI-Public: 10886705028986
• Combination Product (y/n): N
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/06/2021
• 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: Unknown
• Patient Sequence Number: 1