MAUDE Adverse Event Report: OLYMPUS / OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS SEMI-RIGID HYSTEROSCOPY GRASPER; HYSTEROSCOPE (AND ACCESSORIES)

Model Number GYA -5

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 01/19/2021

Event Type  Injury  

Event Description

Physician decided to use hysteroscopy grasper due to iud being embedded in the myometrium upon visualization with the hysteroscopy.The grasper was introduced through the hysteroscope in the usual fashion and after 2 to 3 attempts of trying to grasp the iud, the graspers upon withdrawal from the hysteroscope were noted to have a device failure.One side of the grasper was noted to be missing.There was no evidence of any retained instrument in the uterus; however, the small metal paddle part was never identified.A second pair of graspers were then introduce and used to dislodge the iud, which was delivered without difficulty.A full and thorough hysteroscopic evaluation of the uterine cavity was performed.There was no evidence of any retained instrumentation and a full and detailed survey was performed.Patient was copiously irrigated and all fluid was strained after the procedure.Fda safety report id # (b)(4).

• Brand Name: OLYMPUS SEMI-RIGID HYSTEROSCOPY GRASPER
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS / OLYMPUS MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 11313343
• MDR Text Key: 231577653
• Report Number: MW5099333
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GYA -5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 86