MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE RETRIEVAL BASKET V

Model Number FG-V432P

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report information provided by the customer and investigation findings.The device was not returned to olympus (it was discarded by the facility) so physical evaluation of the suspect device was not possible.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: 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.Check that no abnormality is detected in the action of the handle.If there is any abnormality, the calculus may not be retrieved and/or the basket with calculus engaged may become impacted in the body.When the basket does not open and/or close smoothly, do not apply force but move the forceps elevator, set the endoscope¿s bending angle back, or move the position of the basket until the basket opens and closes smoothly.If the action of opening/closing the basket is forced, the tube may stretch and the resistance in operating the handle may increase.Also, the calculus may not be retrieved, and/or the basket with calculus engaged may become impacted in the body.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.Conclusion: the definitive root cause of the reported event could not be determined.Based on the available information the following is presumed: a likely factor causing the grasping section not to be withdrawn from the bile duct might be the following: lithotomy procedure was repeatedly performed causing deformation of the grasping section.Grasping section was holding a larger calculus than opening of the duodenal papilla.It is likely that a force beyond the resistance strength applied to the product when an attempt was made to crush a calculus by an emergency lithotripter.This caused the wire to break.Due to the following factors, a force beyond the resistance strength might have applied to the product during the calculus lithotomy procedure.Size of the calculus was large.Shape of the calculus.The density of the calculus.The force used to close the grasping section was excessive.

Event Description

The customer reports, during an endoscopic retrograde cholangiopancreatography (ercp) with common bile duct) cbd) stone removal using a single use retrieval basket v, the basket got stuck inside the cbd with the stone inside.It was not possible to eject the stone from the basket, so the physician switched to the emergency lithotriptor / bml-110.All components were correctly assembled.While trying to crush the stone / break the basket to get the device out, the wires of basket broke inside the metallic coiled sheath of device instead of basket breaking at distal end / tip.No excessive force was used during lithotripsy attempt, used the ratchet as instructed (click by click with pauses in between of approx.1 min.).After the wires broke , the physician used a snare to pick up the broken wires pieces that were inside the patient and pulled them back into the sheath again to continue procedure.In the end the physician used traction to get the stone and basket out.As a preventive measure, the physicians decided to place a covered metal stent (in case bleeding should occur).The procedural time surpassed normal ercp duration.(total procedure time approx.2 hrs.).The patient was sedated during the complete procedure using propofol.No additional consequences to the patient have been reported.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.

• Brand Name: SINGLE USE RETRIEVAL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13839988
• MDR Text Key: 293094573
• Report Number: 8010047-2022-04744
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04953170244063
• UDI-Public: 04953170244063
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K955063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-V432P
• Device Lot Number: 18K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• 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; Other