MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,2.7,30,75,CW_STORZ; RIGID ENDOSCOPE

Model Number 242056

Device Problem Crack (1135)

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

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary
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> the device was received and evaluated at the service center.The reported complaint that the scope has a crack on the tip of the scope was confirmed.The following defects were found with the device upon evaluation: outer tube damaged.Distal tip damaged, distal tip has deposits.The defective 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 damage to the outer tube and improper cleaning / maintenance would have caused the deposits on the distal tip.The damage to the distal tip is most likely a result of user error or mishandling, possibly a contact with a sharp instrument during a surgical process.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.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 Description

It was reported by the sales rep that during return inspection, it was observed that the hd epscp,2.7,30,75,cw_storz device had a crack on the tip of the scope.During in-house engineering evaluation, it was determined that the distal tip on the device had deposits.There was no procedure nor patient involvement.No additional information was provided.

• Brand Name: HD EPSCP,2.7,30,75,CW_STORZ
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11361980
• MDR Text Key: 245568018
• Report Number: 1221934-2021-00605
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705028146
• UDI-Public: 10886705028146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242056
• Device Catalogue Number: 242056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 02/22/2021
• 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: Initial
• Patient Sequence Number: 1