MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD; ENDOSCOPE AND ACCESSORIES

Model Number A2500

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

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

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that during an unknown therapeutic procedure, the jaws of the grasping forceps broke off.The stone concrements in the ureter were removed with the forceps.No parts remained in the patient.No patient harm was reported.Reportedly, 2 grasping forceps were used during a single event that broke off.The following 2 patient identifiers for below 2 olympus devices that were involved during a single event.1) patient identifier # (b)(6), grasping forceps, 5 fr.Semi-flexible, standard, model-a2500, (b)(6).(this report) 2) patient identifier # (b)(6), grasping forceps, 5 fr.Semi-flexible, standard, model-a2500, (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation with correction to the initial with information inadvertently left out g2.Additionally, to provide an update with information received through follow up b5, and to provide updates to fields d9, h3, and h4.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The evaluation confirmed the following: the jaws are broken out and are completely detached from the pull rod.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, it is likely that the reported event occurred due to excessive force during use in combination with a twisting movement led to this defect.Additionally, it is possible the damage to the subject device could have been caused by unsuited/inappropriate handling and carelessness, e.G.During reprocessing.However, a specific root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received: the user confirms that both forceps broke during the same procedure.The procedure was for the retrieval of ureteral stone.The fragment of the subject device fell into the ureter.The procedure was prolonged by 5 minutes and the patient did not require additional anesthesia.The procedure was completed with different forceps and the procedure did not result in serious deterioration of the patient's health.The subject device was inspected prior to use and function was determined.The patient did not experience any adverse effects or complications due to the device malfunction and the patient's current health condition is unknown.The procedure outcome is the ureter is free of stones.

• Brand Name: GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD
• Type of Device: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18475264
• MDR Text Key: 332439581
• Report Number: 9610773-2024-00125
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761003483
• UDI-Public: 04042761003483
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2500
• Device Lot Number: 23401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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: GRASPING FORCEPS, MODEL-A2500, (B)(6).
• Patient Outcome(s): Required Intervention