MAUDE Adverse Event Report: OLYMPUS SLIMLINE HYSTEROSCOPY; SEMI-RIGID SCISSORS

Model Number GYS-5

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

Patient underwent operative hysterectomy with endometrial biopsy and resection of uterine septum.Attempted to resect a white hard band of tissue with biopsy forceps but tissue was too tough.The decision was then made to utilize scissors.The tissue was so tough that the 1st pair of scissors broke and a small jaw dislodged in the endocervical canal.The broken piece was identified precisely and removed under direct visualization with biopsy forceps.The patient tolerated the procedure without any adverse event and or complications.Post recovery patient was discharged home in stable conditions.

• Brand Name: SLIMLINE HYSTEROSCOPY
• Type of Device: SEMI-RIGID SCISSORS
• Manufacturer (Section D): OLYMPUS; melville NY 11747
• MDR Report Key: 3672584
• MDR Text Key: 21314818
• Report Number: MW5034877
• Device Sequence Number: 1
• Product Code: HIH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GYS-5
• Device Catalogue Number: 5 FR
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 52