MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number A2500

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

Olympus was informed that during an unspecified therapeutic procedure, when the surgeon used the grasping forceps to grab a ureteral stone, the jaws at the distal end of the grasping forceps broke and fragments fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was completed using another similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device has been returned to olympus for evaluation/investigation.However, the evaluation/investigation is still ongoing.Therefore, the exact cause of the user's experience and the reported phenomenons not yet been determined and is being judged as unknown.However, once the evaluation/investigation is completed or additional significant information becomes available, this report will be updated.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the jaws at the distal end of the grasping forceps are completely broken off and minor damage was found at the basis of the jaws.Also, the transmission wire was found bent.These damages were caused by too much mechanical force when grasping the stones.Furthermore, the investigation found corrosion at both ends of the transmission wire, which was caused by incorrect reprocessing.Thus, this event/incident was attributed to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the grasping forceps without showing any abnormalities.The case will be closed on olympus side with no further actions and the user will be informed about the investigation results.

• Brand Name: GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD
• Type of Device: HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): JOSEF BACHER GMBH; eisenbahnstr. 19; rietheim-weilheim
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15657196
• MDR Text Key: 307065398
• Report Number: 9610773-2022-00496
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761003483
• UDI-Public: 04042761003483
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2500
• Device Catalogue Number: A2500
• Device Lot Number: 21701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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
• Patient Age: 77 YR
• Patient Sex: Male