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

Model Number MCENDO550

Device Problem Optical Problem (3001)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation, however, 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).Results: results pending completion of investigation; conclusions: conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular the scope has a blurry image.It is unknown when this event occurred, whether the product was changed out, whether there was a delay in the procedure, 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 december 9, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 866, 2199, 4582, 3001, 10, 3331, 3259, 3224, 19).Components code: 866 - lenses.Health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 3001 - optical problem.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings #1: 3259 - improper physical structure.Investigation findings #2: 3224 - optical problem identified.Investigation conclusions: 19 - cause traced to user.The actual sample was returned and was visually inspected for damage and looked through the endoscope directly to read some print matter.A visual observation of the internal components using a monocular was conducted.It was discovered that there was a crack on one of the internal lenses which resulted in a blurry visual field.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.

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 12/9/2020.Upon further investigation of the reported event, the following information is new and/or changed: investigation findings: 3259 - improper physical structure.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: 10975111
• MDR Text Key: 220727645
• Report Number: 1124841-2020-00277
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

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: MCENDO550
• Device Catalogue Number: N/A
• Device Lot Number: 747705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 01/13/2021; 07/02/2021
• Supplement Dates FDA Received: 01/29/2021; 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1