MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION TRUCLEAR HANDPIECE; GYNECOLOGICAL INSTRUMENTATION

Model Number 7209807

Device Problems Break (1069); Connection Problem (2900); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the vulcan generator, ce mark made a very loud noise.This occurred during the procedure.There was a delay of less then 30 minutes.A backup device was available to complete the procedure.There were no patient injuries reported.

Manufacturer Narrative

(b)(4).Note: this is not a follow up, this is the initial, 30 day report, however follow up was chosen as the system incorrectly believes there is a duplicate report and as such is rejecting the initial submission.

Event Description

According to the reporter: connector is broken.Occurred during testing.There was no patient involvement, patient injury, medical intervention, patient death, or labeling / packaging issues.The product will be returned.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one device.Damage was noted consistent with removing the cable connector from the control unit with excessive force, likely at a slight angle.Functional testing was not required to test against the reported condition.Product analysis suggests the product was used in a surgical procedure.The reported condition was confirmed.Using excessive force to remove the cable connector from the control unit or removing the cable connector at an angle can damage the internal wiring of the power cord.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Therefore, our investigation was unable to establish a relationship between the device and the reported incident.No enhancements or improvements were generated for the reported condition.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.(b)(4).

• Brand Name: TRUCLEAR HANDPIECE
• Type of Device: GYNECOLOGICAL INSTRUMENTATION
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 75 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 75 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6219280
• MDR Text Key: 64031526
• Report Number: 1643264-2017-00004
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209807
• Device Catalogue Number: 7209807
• Device Lot Number: YE02409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2013
• 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