MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MED REUSABLE ENDOSCOPE; ARTHROSCOPE

Catalog Number 9560101

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent microendoscopic laminectomy (mel) surgery.During surgery, the endoscope image seemed clouded.The device came in contact with the patient.No patient complications were reported.

• Brand Name: MED REUSABLE ENDOSCOPE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7821584
• MDR Text Key: 118393226
• Report Number: 1030489-2018-01172
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00673978085456
• UDI-Public: 00673978085456
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K993021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2018

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 Catalogue Number: 9560101
• Device Lot Number: 1138531(R)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1