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 Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.However, the exact cause of the user's experience and the reported phenomenon could not be determined yet since the evaluation/investigation is still ongoing.As soon as the investigation results and final evaluation are available, this report will be updated.

Event Description

Olympus was informed that during an unspecified therapeutic transurethral procedure, the jaws of the grasping forceps broke and a fragment fell inside the patient's ureter.However, no fragment remained inside the patient since it was reportedly retrieved.The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The evaluation/investigation confirmed that the jaws of the grasping forceps are broken apart.The cause of this damage is mechanical overload by the application of excessive force.Furthermore, corrosion was found on the device.This is caused by improper reprocessing.Therefore, this event/incident was attributed to use error.In addition, 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 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: 6871522
• MDR Text Key: 87619779
• Report Number: 9610773-2017-00108
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• 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: 173W
• Other Device ID Number: 04042761003483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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