MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3000CC HI-FLOW CANISTERS; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72200024

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a hysteroscopy the truclear hysteroscopic fluid management system canister fluid leaked from a cracked canister.A significant amount ¿over 2000mls ¿ of saline irrigation fluid leaked onto the or floor and around the machine itself.Because of difficulty in adequately recording saline deficits, the case was terminated after the polyp shaved down approximately 75%.There were no other complications.There was no report of patient injury associated with this event.Reported in medwatch report (b)(4).

Manufacturer Narrative

Initial report filed in error.Additional information received 8/5/2016 confirmed that smith & nephew is not the manufacturer/distributor of the product used in this event.Customer stated the the fluid collection canisters that were used were purchased through (b)(4).

• Brand Name: 3000CC HI-FLOW CANISTERS
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5839889
• MDR Text Key: 51955137
• Report Number: 3003604053-2016-00038
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 08/05/2016

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: 72200024
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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