MAUDE Adverse Event Report: GYRUS ACMI INC, CYSTOURETHROSCOPE SHEATHS 23FR; SHEATH WITH STANDARD OBTURATOR

Model Number E123-O

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The evaluation could not confirm the reported event.A visual inspection of the device found no scrapes, dents or other damage that shows metal or pieces of the device fell off the unit.The exact cause of the reported complaint could not be conclusively determined.Cross reference: 2951238-2015-00395, 2951238-2015-00400.

Event Description

Olympus was informed that during a diagnostic total laparoscopic hysterectomy procedure, metal flakes from several different components on the device were falling off into the patient's bladder.The surgeon used a grasper and successfully retrieved all the device fragments.The intended procedure was completed with the same device.There was no patient injury reported.The patient was discharged home with no complications.Olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the device was inspected and tested prior to the procedure with no anomalies found.This is two of three reports.

• Brand Name: CYSTOURETHROSCOPE SHEATHS 23FR
• Type of Device: SHEATH WITH STANDARD OBTURATOR
• Manufacturer (Section D): GYRUS ACMI INC,; 136 turnpike road; southborough MA 01882 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5021504
• MDR Text Key: 24679792
• Report Number: 2951238-2015-00399
• Device Sequence Number: 1
• Product Code: FEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E123-O
• Device Catalogue Number: E123-O
• Device Lot Number: GP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1