MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number CB030

Device Problem Energy Output Problem (1431)

Patient Problem Burn(s) (1757)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.

Event Description

Procedure performed: ni.Description: burn at the trocar orifice.Electric arches with epix scissors ref (b)(4) lot 1349864.The dr [name] think that it could cause burning to the skin.Patient status: injury occurred.Type of intervention: ni.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection was performed on the event unit and there were no non-conformances observed.Testing was performed on the event unit.However, the complainant's experience could not be replicated, as the event unit met current specifications.Applied medical has reviewed the details surrounding the event and related products.Based on the description of the event and evaluation of the returned unit, there is no indication that the device malfunctioned during use.At this time, applied medical is unable to determine the cause of the patient injury or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: ni.Description: burn at the trocar orifice.Electric arches with epix scissors ref (b)(4) lot 1349864.The dr [name] think that it could cause burning to the skin.Additional information received by email from applied medical representative on 19sep19: i met ms.[name] today in the operating room of the clinic.Here are the things she remembers.The scissors did not have insulation problem.The monopolar energy was not activated without contact to tissue.The burn was located at the port of the trocar on the skin.The product has not been resterilized.The trocar used with the scissors was a re-sterilizable trocar.She does not remember if the blades came into contact with the trocar (or surrounding area) while the monopolar energy was active.The blades were not cleaned during the procedure.Additional information received by email from applied medical representative on 25sep19: dr.[name], surgeon, confirms to me that the patient is well.Patient status: injury occurred; patient is well.Type of intervention: ni.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8829222
• MDR Text Key: 152324892
• Report Number: 2027111-2019-00530
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)220221(30)01(10)1349864
• Combination Product (y/n): N
• PMA/PMN Number: K062169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1349864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR