MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12 AND 30 TELESCOPE; GRASPING FORCEPS, SINGLE ACTION

Model Number A20710A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.Despite multiple followup attempts by phone and in writing, no further information is available regarding the role or performance of the forceps device in the event, the name of the procedure, the sequence of events, whether and how the procedure was completed, the patient¿s current state, or the make and model number of the stone crushing device.It has also not been confirmed if the forceps device is the same device as the stone crusher.The oem performed a review of the device history record and found no related anomalies at the time of manufacturing release.As a preventive measure, the forceps instructions for use document has pre-procedure instructions to visually inspect the product and verify manual operation.The document also states, ¿if the instrument is damaged or does not function properly, replace it.¿ the document also specifies the compatible olympus devices for use with the forceps, and states that for maintenance, the distal tip should be lubricated with olympus a0273 lubricant.

Event Description

Two of 2.Olympus was informed that during an unknown procedure, the forceps device was present when a separate cystoscope sheath device became bent while inside the patient, trapping and breaking a stone crusher.All device fragments were retrieved from the patient.There was no reported patient injury.

Manufacturer Narrative

The forceps device was returned to olympus for evaluation.The evaluation found that the end pin was detached from the shaft.This prevented the jaws from opening and closing when the handle was actuated.There was no damage or deformation in the telescope channel.It has still not been confirmed whether this forceps device is the same device as the reported broken stone crusher.If additional information is received, this reported will be updated accordingly.

• Brand Name: GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12 AND 30 TELESCOPE
• Type of Device: GRASPING FORCEPS, SINGLE ACTION
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7843779
• MDR Text Key: 119533428
• Report Number: 2951238-2018-00495
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761019989
• UDI-Public: 04042761019989
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

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: Health Professional
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Device Lot Number: 182W-0038
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS CYSTOSCOPE SHEATH, MODEL A20915A; UNKNOWN MODEL STONE CRUSHING DEVICE