MAUDE Adverse Event Report: SPIGGLE & THEIS MEDIZINTECHNIK GMBH SPIGGLE & THEIS PANETTI SUCTION SEPERATOR

Model Number 10-808-12

Device Problems Break (1069); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2019

Event Type  malfunction  

Event Description

(b)(4) is reporting this incident as the importer and on the behalf of the manufacturer as their us agent.The manufacturer has sent the fda an exemption request from reporting the same mdr incident to the following address: (b)(4).Panetti suction separator 45a, 2.5mm, 13cm, luer-lock, suction hole in angle (30-1844).A complaint was reported to spiggle & theis (b)(4) (manufacturer) by the (b)(6) authorized representative on may 16, 2019.A blade, 2.5mm in diameter, of a panetti suction separator is broken during an otological operation (endoscopic tympanotomy).The broken piece fellb5 into the patient and could be removed from the surgical field.The planned operation was completed and no patient damage, side effects, or injuries were reported.The faulty instrument was returned on june 14, 2019 and the manufacturer analyzed the returned instrument before determining that the instrument was not being used for its intended purpose by the medical professional.The manufacturer performed a risk assessment and a test evaluation for the panetti suction separator was conducted.Testing with the ametek lloyd ls1 universal testing machine is intended to provoke an analog fracture point and determined the required force.Only new instruments were used for the examination.The measured values collected were primarily used to find methods for conducting the audit.Two different tests were carried out: applying the test force to the distal end of the separator while clamping the distal shaft of the working part to determine the force of the maximum torque which can be applied to the circular section knife soldering/welding joint.Applying the test force to the distal end of the separator when clamping the distal shaft of the working part to determine the shear force.It was determined that the instrument was not being used as it was intended on soft tissue and was most likely being used to pry or used with excessive force.These instruments are designed to be used on soft tissue surgery only and not for bone surgery.A field safety notice to update the instructions for use (ifu) to give more detail about the intended use for the instruments.The instrument is to be used for soft tissue surgery only, as it was intended, was issued on july 11, 2019.This ifu applies to all the reusable surgical panetti instruments including jedmed product numbers: 30-1834 panetti suction microhook (1mm); 30-1835 panetti suction microhook (1.5mm); 30-1836 panetti suction microhook (2.0mm); 30-1838 panetti suction separator (2.5mm); 30-1840 panetti suction separator (2.0mm); 30-1842 panetti suction knife (2.5mm; left); 30-1844 panetti suction separator (2.5mm); 30-1846 panetti suction knife (2.5mm; right); 30-1852 panetti suction sickle knife; 30-1856 panetti suction dissector (left); 30-1858 panetti suction dissector (right); 30-1860 panetti preyer suction finder; 30-1870 panetti-an suction sickle knife.Jedmed instrument company has contacted all customers who have purchased a panetti reusable surgical instrument and have sent the field safety notice and updated ifu.

• Brand Name: SPIGGLE & THEIS PANETTI SUCTION SEPERATOR
• Type of Device: SUCTION SEPERATOR
• Manufacturer (Section D): SPIGGLE & THEIS MEDIZINTECHNIK GMBH; burghof 14; overath, 51491 ; GM 51491
• Manufacturer Contact: martina zell ; burghof 14; overath, 51491 ; GM 51491
• MDR Report Key: 8848269
• MDR Text Key: 216596688
• Report Number: 1926681-2019-00729
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10-808-12
• Device Lot Number: 045/02-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Distributor Facility Aware Date: 07/11/2019
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1