MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 0 DEG, 10 X 330MM

Model Number	4K LAPAROSCOPE, 0 DEG, 10 X 330MM
Medical Device Problem Codes	Material Fragmentation (1261); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the edge of the optic is too sharp which results in plastic debris.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.Update dw 22-jan-2024: further information were provided that the reported event was noticed at the end of a surgery.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional info: b5.H6: medical device problem code updated to 4013 based on follow-up information provided in b5.
Event or Problem Description
Update dw 30-jan-2024: further information were provided that the reported event occurred during a minimal invasive hernia surgery.Surgery was finished successfully with a new device without further issues.It was further reported that due to the sharp end a balloon was damaged but no plastic debris was introduced into patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.It was reported that the edge of the optic is to sharp which results in plastic debris.Further information was provided that the reported event occurred during a minimal invasive hernia surgery.Surgery was finished successfully with a new device without further issues.It was further reported that due to the sharp end a balloon was damaged, but no plastic debris was introduced into patient.The reported event was confirmed.The manufacturer evaluation revealed dents and damages at the distal end which resulted in the reported sharp edges.The most likely cause is attributed to improper device handling such as hitting the device with another instrument, leveraging the device during use and/or applying excessive force.

• Brand Name: 4K LAPAROSCOPE, 0 DEG, 10 X 330MM
• Common Device Name: LAPAROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18580222
• Report Number: 1220246-2024-00533
• Device Sequence Number: 7031096
• Product Code: GCJ
• UDI-Device Identifier: 00888867029705
• UDI-Public: 00888867029705
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K941541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4K LAPAROSCOPE, 0 DEG, 10 X 330MM
• Device Catalogue Number: AR-3351-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 01/22/2024; 07/01/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/14/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown