MAUDE Adverse Event Report: JOIMAX GMBH TESSYS INSTRUMENT SET; MANUAL SURGICAL INSTRUMENTS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Date 09/11/2023

Event Type  Injury  

Event Description

A joimax tessys instrument set was used on a patient undergoing endoscopic spinal surgery on t12-l1.The surgery was uneventful and the patient was discharged.Postoperatively, the patient presented to the hospital emergency department and was diagnosed with an infection.The patient was admitted to the hospital for 5 days to treat the infection.The infection was treated successfully and the patient was discharged.Follow-up discussion with the distributor alleged that the infection may have been caused by rusted joimax instruments that were improperly reprocessed by the hospital.

Manufacturer Narrative

The joimax tessys device still resides at the user facility to the manufacturer's knowledge.No device identifiers are available at this time.Approximately one year ago (october 17, 2022), two joimax representatives visited the hospital to perform preventive maintenance; during this visit, extensive rust was observed on the ilessys and tessys instrument sets and joimax identified that the devices had been improperly reprocessed.The joimax representatives informed the hospital of these findings and offered to provide retraining in accordance with the device labeling.The hospital declined the retraining.The device user manual and reprocessing instructions clearly state that after cleaning and disinfection, all medical devices must be inspected for function, corrosion, damaged surfaces, chipping or / and cleanliness.Specifically, "if a deterioration / defect is determined, then the instrument is to be segregated immediately and may not be used further.Inadequate or omitted reprocessing can lead to infection or inflammation of the patient".Based on the information reviewed, the root cause of the infection was likely attributed to improper device reprocessing (use error).Infection is identified in the system risk assessment.Manufacturer reference #: (b)(4).

• Brand Name: TESSYS INSTRUMENT SET
• Type of Device: MANUAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): JOIMAX GMBH; amalienbadstrasse 41; raumfabrik 61; karlsruhe, 76227 ; GM 76227
• Manufacturer (Section G): JOIMAX GMBH; amalienbadstrasse 41; raumfabrik 61; karlsruhe, 76227 ; GM 76227
• Manufacturer Contact: rainer steegmuller ; amalienbadstrasse 41; raumfabrik 61; karlsruhe, 76227 ; GM 76227
• MDR Report Key: 18319616
• MDR Text Key: 330393510
• Report Number: 3005083075-2023-00002
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 04250337101239
• UDI-Public: 04250337101239
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/13/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male