MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION TRUCLEAR CONTROL UNIT; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 7209808

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the connector is damaged.There was no patient injury.

• Brand Name: TRUCLEAR CONTROL UNIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 6270105
• MDR Text Key: 65518767
• Report Number: 1643264-2017-20005
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132015
• 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: 12/28/2016

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: 7209808
• Device Catalogue Number: 7209808
• Device Lot Number: YF1433
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1