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 Detachment Of Device Component (1104); Difficult to Open or Close (2921)

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

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transurethral lithotripsy (tul) procedure, the jaws of the grasping forceps could not be opened while attempting to grasp tissue.The device was then withdrawn from the patient and it was noticed that the axel pin at the distal end of the grasping forceps had detached and had fallen inside the patient.No further information was provided but it was reported that the suspect medical device had been inspected and tested before the procedure and that no abnormalities were detected at that time.There was no report about an adverse event or patient injury.

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 2016-09-15).The evaluation/investigation confirmed that the axel pin at the distal end of the grasping forceps had detached.However, no part was missing since the axel pin was returned as well.Furthermore, the instrument was found to be in poor condition with corrosion, contamination and residues due to improper reprocessing.The cause of this damage and the detached axel pin is mechanical overload after it became loose due to the corrosion.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the grasping forceps without showing any abnormalities.The case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes.In addition, the user will be informed about the investigation results and retrained to correctly reprocess, inspect, test and use the olympus medical devices.

• 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
• Manufacturer (Section G): BACHER JOSEF GMBH; eisenbahnstrasse 19; rietheim-weilheim
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6879041
• MDR Text Key: 87479053
• Report Number: 9610773-2017-00111
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• 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: 155W
• Other Device ID Number: 04042761003483
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1