MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ENDOSCOPE 5.5MM; LAPAROSCOPE, GENERAL

Model Number MCENDO550

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular a defective endoscope.It is unknown when did the problem occur, if there was delay, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on july 2, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes (4114, 3224, 19).Method code : 4114 - device not returned, results code : 3224 - optical problem identified, conclusions code : 19 - cause traced to user.The sample was not returned so a direct investigation could not be performed; however, past product complaints were reviewed for similar issues and the most likely root cause is improper handling caused the internal lens to break.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: ENDOSCOPE 5.5MM
• Type of Device: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10227341
• MDR Text Key: 200843564
• Report Number: 1124841-2020-00147
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00699753018952
• UDI-Public: (01)00699753018952
• Combination Product (y/n): N
• PMA/PMN Number: K092789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MCENDO550
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1