MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION HYSTEROSCOPIC FLUID MONITOR SYSTEM STAND; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBING SETS

Model Number 7210165

Device Problem Break (1069)

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

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Since the lot number was not provided, this information cannot be determined.

Event Description

According to the reporter, the support was broken on the scale of the device.This was noticed while setting up for the procedure.

• Brand Name: HYSTEROSCOPIC FLUID MONITOR SYSTEM STAND
• Type of Device: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBING SETS
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 75 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 75 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6194769
• MDR Text Key: 62981740
• Report Number: 1643264-2016-20008
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210165
• Device Catalogue Number: 7210165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1