MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,4.0,30,167,MITEK RIGID ENDOSCOPE

Catalog Number 242018

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

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 at service center and evaluated. The complaint can be confirmed. As per the service report outer tube damaged, distal tip damaged, shaver damage to distal tip, distal tip has deposits -optical system, broken lenses in optical system. The root cause for the reported failure could be user mishandling. However,definitive root cause cannot be determined. A manufacturing record evaluation was performed for the finished device product (242018) and lot number ((b)(4)), and no non-conformances were identified. 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. Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that the hd epscp,4. 0,30,167,mitek had a burnt tip. They continued the case with the scope with no patient harm or delay.

• Brand Name: HD EPSCP,4.0,30,167,MITEK
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8786362
• MDR Text Key: 151103711
• Report Number: 1221934-2019-57632
• Device Sequence Number: 1
• Product Code: HRX
• 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

• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/12/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 242018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage