GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12? AND 30? TELESCOPE A20710A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12? AND 30? TELESCOPE A20710A manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[119533428] 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.
Patient Sequence No: 1, Text Type: N, H10


[119533429] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2018-00495
MDR Report Key7843779
Date Received2018-09-04
Date of Report2018-09-18
Date of Event2018-08-02
Date Mfgr Received2018-08-30
Date Added to Maude2018-09-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12? AND 30? TELESCOPE
Generic NameGRASPING FORCEPS, SINGLE ACTION
Product CodeGCP
Date Received2018-09-04
Model NumberA20710A
Catalog NumberA20710A
Lot Number182W-0038
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG US


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-04

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