MAUDE Adverse Event Report: CONMED UTICA STEALTH 32 LHOOK LAP ELEC PKG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 60-5274-132

Device Problem Material Fragmentation (1261)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

Conmed japan reported on behalf of their customer that the device, 60-5274-132, stealth 32 lhook lap elec pkg was being used on (b)(6) 2023 during a laparoscopic total hysterectomy procedure and ¿it was reported that the tip of electrode detached and dropped off during extraperitoneal operation.There was no shedding into the patient's body.On (b)(6) updated: ¿it was confirmed that the tip of the shaft was damaged and there were broken pieces, rather than the electrode tip coming off.¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

Manufacturer Narrative

Received one 60-5274-132 in opened original package.Lot number was verified.Performed a visual inspection, the complaint was confirmed.It was confirmed that the tip of the shaft was damaged and there were broken pieces.The root cause cannot be determined; however, based upon the evaluation and the photos, the likely cause may be due to excessive force being used during removal of eschar from the tip.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 22 reports, regarding 23 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: examine this device prior to use for damage.Do not use if damage is found.The ifu also advises the user that should eschar adherence occur on the 60-5272 series, the electrode tips can be cleaned with an electrosurgical scratch pad.On the 60-5274 series, with eschar-resistant coating, any adhering can be easily wiped away with a sterile, moistened sponge.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of their customer that the device, 60-5274-132, stealth 32 lhook lap elec pkg was being used on (b)(6) 2023 during a laparoscopic total hysterectomy procedure and ¿it was reported that the tip of electrode detached and dropped off during extraperitoneal operation.There was no shedding into the patient's body.Nov 1st updated: ¿it was confirmed that the tip of the shaft was damaged and there were broken pieces, rather than the electrode tip coming off.¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: STEALTH 32 LHOOK LAP ELEC PKG
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18064635
• MDR Text Key: 327270668
• Report Number: 1320894-2023-00244
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)270925(10)202209261
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K952204
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 202209261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic