MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM CONTROL UNIT; GYNECOLOGICAL INSTRUMENTATION

Model Number 7210164

Device Problem Break (1069)

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

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not been received.A supplemental report will be sent if device is received.

Event Description

According to the reporter, a piece fell off the connector of fluid base that connects wires to base.This event occurred during testing.There was no patient involvement, injury, death, medical intervention, or labeling/packaging issues.The device will be returned.Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of new information.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Part of the cable connector shell has become unattached and is missing.The connector shell is normally connected by threads to the back of the cable connector housing.No damage to the threaded connector was noted during evaluation.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.The root cause of the observed condition could not be reliably determined.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM CONTROL UNIT
• Type of Device: GYNECOLOGICAL INSTRUMENTATION
• 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: 6297049
• MDR Text Key: 66434462
• Report Number: 1643264-2017-20011
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210164
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1