MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number A2500

Device Problems Bent (1059); Sticking (1597); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4)(returned to omsc on (b)(6) 2015).The evaluation/investigation confirmed that the jaws had completely detached from the instrument.Furthermore, the grasping forceps' distal end is severely deformed and the fixing pin of the jaws is missing.Causal for this damage and the detachment of the jaws is mechanical overload by the application of excessive force.As clearly stated as a caution note in the instructions, the instrument must never be inserted or withdrawn with excessive force as otherwise there is a risk of damaging the grasping forceps.The user apparently did not follow these instructions as the damage of the grasping forceps and the detachment of the jaws were caused by the application of excessive force.Therefore this event/incident was attributed to abnormal use/off-label use and the case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and pro re nata retrained to correctly use the olympus medical devices.

Event Description

Olympus was informed that during a therapeutic transurethral ureteral stent replacement procedure, the shaft of the grasping forceps was bowed and the distal end got stuck inside a rigid cystoscope.The jaws then detached from the instrument when the inexperienced physician forcibly advanced the grasping forceps.No fragments remained inside the patient as they were reportedly retrieved by unknown approach.The intended procedure was successfully completed with another similar device and there was no report about an adverse event or patient injury.Furthermore, an x-ray was taken postoperatively where no foreign objects were noted inside the patient.

• Brand Name: GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD
• Type of Device: HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer (Section G): BACHER JOSEF GMBH; eisenbahnstrasse 19; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 5273620
• MDR Text Key: 33438994
• Report Number: 9610773-2015-00060
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2500
• Device Catalogue Number: A2500
• Device Lot Number: 149W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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
• Patient Age: 70 YR