MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB050, 5X38CM EPIX INLINE SCISSORS 10/BX; HET

Model Number CB050

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident and sterile units device.They have been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.This report is to follow up with medwatch - mw5065449.

Event Description

Operative laparoscopy- "scissor insulation towards distal top appeared to melt and appeared to damage the left fallopian tube.They were using scissors to dissect the peritoneum on the posterior cul de sac.While they were dissecting, they attempted to use monopolar energy, and noticed the power to the scissors was working intermittently despite their constant pressing of the peddle.They received energy ever so often despite having foot on the pedal.The connection from the insulation cord to the back of the scissors was checked and when it was checked and re-fastened, it seemed to fix it.The doctors and medical staff noticed that the patients left leg was jumping intermittently.They pulled the scope back and saw damage to the fallopian tube at which point they removed scissors and saw melted insulation.They were using karl storz 5mm grasper, karl storz 0 degree 5mm laparascope, cb050, re-usable karl storz 5mm trocar, and 5mm karl storz monopolar cord.The settings on energy were set at 40 degree cut and 70 degree coagulation; both energy sources were being used.They determined the damage to the fallopian tube was the same area as the melted portion of insulation.The insulation defect was right above where the damage was.The patient was hurt; the left fallopian tube was damage and they performed a neo salpingoplasty." type of intervention - "neo salpingoplasty".Patient status - "the patient was injured as the fallopian tube was damaged".Additional information received via medwatch report# mw5065449 on october 26, 2016- "the scissor was being used to dissect the peritoneum in the posterior cul-de-sac when the surgeon noticed the left fallopian tube was being burned.At the time, the fallopian tube was touching the insulated shaft of the scissor, 1.5 inches away from the blades.The scissors were immediately removed and inspected.This is when the burn on the shaft of the scissor was first seen by the doctor.The shaft was burned enough to expose the metal underneath.The scissor was then removed from the sterile field and a new scissor (b)(4) was used in its place.The scissor in question has been sent back to the mfr for eval.".

Manufacturer Narrative

The event unit was returned for evaluation.Upon evaluation, engineering confirmed the complainant's experience of insulation damage.They also noted that the burns on the sleeve ended in a section where a gash in the shaft insulation was visible.Further inspection revealed that the metal shaft had been scored and the marks that remained followed the same path as the burn marks.Engineering's analysis has determined that the compromised insulation sleeve was due to damage by another instrument used during the procedure.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

Event Description

Additional information received december 7, 2016."the clinical development team visited (b)(6) surgery center on (b)(6) 2016 regarding (b)(4) (a cer referencing insulation damage).In discussions with the scrub tech, she commented that, in her opinion, the rotation knob heating up (cer 2016-1035) was not a serious issue and the concerns from the surgeon were most likely stemming from the incident related to the insulation damage for (b)(4).".

• Brand Name: CB050, 5X38CM EPIX INLINE SCISSORS 10/BX
• Type of Device: HET
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138000
• MDR Report Key: 6090034
• MDR Text Key: 59518451
• Report Number: 2027111-2016-00722
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915124519
• UDI-Public: (01)00607915124519(17)181227(30)01(10)1260313
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/27/2018
• Device Model Number: CB050
• Device Catalogue Number: 101098801
• Device Lot Number: 1260313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention