MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT RESECTOSCOPIC SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Device Problem Break (1069)

Patient Problems Pain (1994); Nonresorbable materials, unretrieved in body (2276); Treatment with medication(s) (2571)

Event Date 02/20/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an electrosurgical procedure on (b)(6) 2014.During the procedure, a small piece of the plastic sheath was torn from the device and was retained in the patient's uterus.The physician could not retrieve the piece as the patient felt pain and requested the procedure to be stopped.The patient was given antibiotics and a follow-up outpatient hysteroscopy was arranged.Additional information has been requested.

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: VERSAPOINT RESECTOSCOPIC SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC. - GYRUS MEDICAL LTD; fortran road, st. mellons; cardiff CF3 OLT; UK CF3 OLT
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3695853
• MDR Text Key: 4301416
• Report Number: 2210968-2014-03445
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 03/24/2014
• 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
• Patient Outcome(s): Other; Required Intervention