MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RETRIEVAL BASKET V

Model Number FG-V431P

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/13/2022

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using a single use retrieval basket v, the basket tore off during emergency lithotripsy and could only be removed surgically.The suspect device cannot be returned for evaluation, it was discarded by the customer.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to provide additional information reported by the customer.New information is reported in b5.

Event Description

Update: additional information provided by the customer: the procedure being performed was an emergency lithotripsy -with the pejcl system.The handle of the basket was cut off and an attempt was made to remove the basket from the bile duct without using the endoscope.In this case, the basket did not tear at the predetermined breaking point at the front, but at approx.20 cm.Then the basket could not be removed from the bile duct.The handle was cut off for emergency lithotripsy and disposed of in the trash.An open biliary surgery with abdominal incision was done and the basket was removed along with the stone and gallbladder.The basket was discarded in the operating room.There were no anatomical or procedural challenges that contributed to the breakage of the device, the was broken.When turning the wheel on the handle, the wires of the basket did not break in the front but about after 20 cm.The territory manager cannot evaluate the handle and the spiral from the company pejcl, (to determine if there were any technical issues).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, since the device was not returned for evaluation, the root cause could not be determined.However, based on past investigation results, it is likely that during the emergency lithotripsy (with the cook emergency handle), various factors such as the size, hardness or shape of the calculus, a load beyond the resistance strength, etc., may have applied to the product.As a result, the operation wire was broken (tore off), and the basket fell off inside the patient.Also, due to various factors such as the size, hardness or shape of the calculus, the basket could not be retracted.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿before use, thoroughly review the instruction manuals for this instrument and the lithotripter (bml-110a-1) to determine the proper method of use.Using the instrument and lithotriptor without thoroughly reviewing their manuals could cause patient injury.¿do not use this instrument if the target calculus is found to be impossible to retrieve through preoperative diagnosis, interoperative contrast enhancing, or after papillotomy/papillary dilation.Do not use this instrument to grasp multiple calculi at one time.Doing so may make it impossible to remove the basket (with calculi engaged) from the patient.Use this instrument with a hospitalization plan ready and the understanding that, if the calculus is too hard to be crushed by the lithotriptor (bml-110a-1), the instrument may become irreversibly damaged and open surgery may have to take place in order to remove the calculus." "when using the bml-110a-1 mechanical lithotriptor, there is a possibility that the basket could become damaged as shown in section10.8, ¿emergency treatment¿.Use the bml-110a-1 with the understanding that the basket could become damaged and open surgery may have to be performed.Repetition of calculus retrieval will deform and/or deteriorate this instrument.Deformation and/or deterioration may make it difficult to retrieve a calculus or could cause the basket with calculus engaged to become impacted in the body.If calculus retrieval needs to be repeated in a single case, be sure to inspect the action and the appearance before each retrieval.Stop use if any abnormality (e.G., basket wire is cut or worn, tube sheath is bent, etc.) is detected during the inspection." "when using the bml-110a-1, do not withdraw the tube of this instrument from the endoscope while the endoscope is inserted into the patient body.If the endoscope is withdrawn from the patient body, after the tube of this instrument is withdrawn from the endoscope which is still in the patient body, (i.E., if the endoscope is withdrawn from the patient body while the only operation wire of this instrument is still in the endoscope), the forceps elevator of the endoscope contacts the operation wire of this instrument during the withdrawal of the endoscope and may kink the wire.The kink of the operation wire may make it impossible that the distal end of the coil sheath of the bml-110a-1 is inserted into the patient body over the operation wire till the distal end reaches the target calculus and enable the bml-110a-1 to function.When using the bml-110a-1, either withdraw the tube together with the endoscope from the patient body or withdraw the tube of this instrument from the patient body after withdrawing the endoscope from the patient body.Then, insert the coil sheath of bml-110a-1 into the patient body over the operation wire of this instrument.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer.B5 updated accordingly.

Event Description

It was reported that there were no abnormalities in the patient¿ condition after the surgical procedure.It was reportedly ¿problem-free open che with t-drain.¿ the surgical intervention did not cause any consequential damage.The patient recovered in a approximately one week.

• Brand Name: SINGLE USE RETRIEVAL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15809678
• MDR Text Key: 303801060
• Report Number: 9614641-2022-00632
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04953170244056
• UDI-Public: 04953170244056
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K955063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-V431P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 02/01/2023; 02/23/2024
• Supplement Dates FDA Received: 11/23/2022; 02/13/2023; 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention