MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,1.9,30,60,CW_STORZ; RIGID ENDOSCOPE

Model Number 242048

Device Problems Break (1069); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the shaft on the scope was bent, was confirmed.The following defects were found with the device upon evaluation : outer tube damaged, needle, outer tube bent, outer tube damaged, distal tip, distal tip has deposits, optical system, optical components, broken lenses in optical system.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 device, including the broken lenses, probably due to fall.The deposits on the distal tip can be attributed to lack of cleaning and maintenance activities on the device by the customer.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.Udi: (b)(4).

Event Description

It was reported by sales rep via email that post operatively to an unknown procedure it was found that the shaft on a hd arthroscope/sinuscope, ep, 1.9mm, 30 deg, 60mm (storz style) was bent.No surgical delay or patient consequence reported.

• Brand Name: HD EPSCP,1.9,30,60,CW_STORZ
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS SARL TOLLER MITEK; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10626955
• MDR Text Key: 209792862
• Report Number: 1221934-2020-02862
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705028108
• UDI-Public: 10886705028108
• 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: 09/18/2020

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
• Device Operator: Health Professional
• Device Model Number: 242048
• Device Catalogue Number: 242048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1