MAUDE Adverse Event Report: OLYMPUS SURGICAL TECHNOLOGIES AMERICA OLYMPUS STONE CRUSHING FORCEPS; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number A20710A

Device Problems Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528)

Patient Problems Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 01/31/2020

Event Type  Injury  

Event Description

Event: malfunction of olympus brand lithotrite (optical bladder stone grasper / crusher) causing fracture of inner resectoscope element ceramic tip, resulting retained foreign bodies which required cystoscopic removal several days later.Brief description: malfunction of the lithotrite grasper, used in an attempt to fragment a bladder stone.The grasper became stuck open and could not be removed easily through the resectoscope lumen.Removal of the grasper was able to be accomplished only after gently rotating the instrument within the resectoscope sheath resulted in fracture of the small ceramic tip of the inner sheath of the resectoscope into many pieces, likely due to traction required to pull the lithotrite through the resectoscope.Some of the residual foreign body fragments were grasped and removed, but several pieces remained and required endoscopic removal 4 days later on (b)(6) 2020.Radiographic confirmation of complete foreign body removal was performed at the end of the case on (b)(6) 2020.Detailed description: the 1 cm stone was engaged with the lithotrite along its lateral oblong aspect, but unfortunately the lithotrite broke in the open position and would not close completely to be removed from the resectoscope.The inner resectoscope element plus lens element and lithotrite grasper were uncoupled as a jointed unit from the outer resectoscope sheath and a gentle attempt was made to manually close the jaws by creating opposition with the outer resectoscope piece.However, the urologist was unable to gain apposition of these surfaces due to the feel of soft, probable bladder neck tissue between the lithotrite jaws and the outer element.The outer element is the shortest length of the resectoscope assembly and due to the long prostatic fossa in this case, the outer element would not reach the middle of the bladder, safe from trapping the bladder neck tissue between the jaws of the lithotrite and the outer element.It was unclear the jaws were open or partially fixed manner, or simply open with one jaw positioned down by gravity.The urologist disengaged the inner resectoscope from the lithotrite-lens complex and very gently rotated the lens and lithotrite units in a counterclockwise 180 degrees manner with light traction, to take advantage of the offset angle of the inner element tip to help close the jaws of the lithotrite to the point where it could be brought into the inner element.Upon gentle steady removal of the lens and lithotrite through the inner element, there was a feeling of release as the lithotrite fully entered the inner element, after which the lens and lithotrite were removed without any tension.After removal of the lithotrite it was inspected and found to be intact but still fixed open somewhat.It was placed on the back table for eventual mechanical inspection.On replacement of the lens with a standard bridge, the inner element was noted to be lacking the offset insulation ceramic tip.Several white ceramic fragments numbering 6 to 8 were noted in the prostate fossa and bladder floor.Grasping forceps and a few of the smaller fragments were able to be removed.There were approx 4-6 larger fragments remaining that were too large to grasp and remove through the resectoscope.Due to mild bleeding from the turp portion of his procedure preventing optimal visualization, as well as the need to return on another day to treat the remaining stone with alternative technology, the procedure was terminated following foley placement.A kub flat plate was obtained in the pacu documenting retained foreign body fragments.The pt returned to the operating suite 4 days later and all residual foreign body fragments were removed, confirmed by on-table radiography, through a larger diameter resectoscope.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS STONE CRUSHING FORCEPS
• Type of Device: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS SURGICAL TECHNOLOGIES AMERICA
• MDR Report Key: 9804996
• MDR Text Key: 182722157
• Report Number: MW5093593
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

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: Lay User/Patient
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR