MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL, HANDPIECE TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 7209807S

Device Problem Connection Problem (2900)

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

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the truclear handpiece could not be connected to the console.There was no backup device, so the procedure was completed with manual instruments including forceps and scissors along with a cautery device.There was no reported delay or patient impact associated with this event.

Manufacturer Narrative

Complaint of "handpiece could not be connected to the console" could not be confirmed.Hand piece was installed into receptacle on test control unit with no trouble.No damage was found on connector.Hand piece was installed on 2 other control unit receptacles with no trouble.Product passed functional testing including high speed testing (100-2500 rpms) with blade installed.Unit passed functional tests on a known good control unit with footswitch.All functions performed as expected.No failure was detected, device operated within specification.

• Brand Name: SVCE REPL, HANDPIECE TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5941042
• MDR Text Key: 54762043
• Report Number: 1643264-2016-00163
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• 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: 08/12/2016

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 Catalogue Number: 7209807S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• 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