MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR INCISOR PLUS BLADE 2.9; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72202536

Device Problem Device Slipped (1584)

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

Event Date 08/15/2013

Event Type  malfunction  

Event Description

During a hysteroscopic polypectomy procedure the truclear incisor plus blade 2.9 would not lock.The sales rep was present during this incident.When dr.Inserted the blade into the patient's cavity, the window lock would not function.The inner lumen of the blade kept skipping.The dr.Tried re-snapping and unplugging and rotating the blade manually.Finally, he was able to get it to window lock and they finished the case with this "suspect" blade.No product returning for evaluation.

Manufacturer Narrative

No product returned for evaluation.Method: no product returned for evaluation.Conclusion: other, no product returned for evaluation.During a hysteroscopic polypectomy procedure the truclear incisor plus blade 2.9 would not lock.The sales rep was present during this incident.When dr.Inserted the blade into the patient's cavity, the window lock would not function.The inner lumen of the blade kept skipping.The dr.Tried re-snapping and unplugging and rotating the blade manually.Finally, he was able to get it to window lock and they finished the case with this "suspect" blade.No product returning for evaluation.If the product is received in the future the complaint can be reopened and evaluated.Smith and nephew will continue to monitor for trends of the reported complaint condition for further occurrences.Root cause could not be determined with any confidence.

• Brand Name: TRUCLEAR INCISOR PLUS BLADE 2.9
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4836389
• MDR Text Key: 5906847
• Report Number: 3003604053-2015-00022
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 06/10/2015

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 Expiration Date: 04/30/2016
• Device Catalogue Number: 72202536
• Device Lot Number: B33531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1