MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  Injury  

Event Description

It was reported during a diagnostic renal pelvic and ureteral examination, when the forceps was inserted into the forceps channel of the uretero-reno fiberscope, there was some resistance to insertion and a black foreign object fell from the tip into the renal pelvis.The foreign object was recovered using forceps.The doctor then replaced the scope and completed the procedure.There was no prolongation of the procedure or additional anesthesia.Upon customer follow-up, it was reported that the rubber stopper of the forceps/irrigation plug used in the previous case was partially broken and went inside the scope channel.During reprocessing, the inside of the channel was not brushed completely and the broken forceps/irrigation plug pieces were not completely removed and subsequently fell into the patient in the next procedure.There was no reported patient impact.

Manufacturer Narrative

This report is related to the following linked patient identifier: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus, and the following was observed: it was confirmed that part of the biopsy valve of the forceps/irrigation plug was chipped.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it was determined that the foreign object (black rubber-like appearance) was part of the biopsy valve of the forceps/irrigation plug tightening knob.The reported issue occurred because the tip of the endo therapy accessory was likely open during insertions/removal.The device was damaged because it was inserted and removed while the device was out of the sheath.Also, it was likely inserted/removed at an angle to the biopsy valve which caused overload on the rubber part of the device.As a result, the chipped rubber piece moved inside the biopsy channel as the endo therapy accessory was inserted and removed, ant then fell off from the tip.However, the root cause could not be identified.The event can be detected/prevented by following the instructions for use (ifu) in section: "forceps/irrigation plug (isolated type) maj-891.(section 3.5) - inspection of the combination with the endo-therapy accessory: prevention measures".This supplemental report includes a correction to g2 and h8 from the initial medwatch.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19071848
• MDR Text Key: 339730139
• Report Number: 9610595-2024-07401
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: MAJ-891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: URF-P7 (SN (B)(6)).
• Patient Outcome(s): Required Intervention