MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH NWH MINOR PACK; GENERAL SURGERY TRAY

Lot Number 762211

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Shaking/Tremors (2515)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Patient of dr.(b)(6) with diagnosis hashimoto's for a total thyroidectomy.Rm.12.Patient positioned as per usual with torso to mid-thigh wrapped in draw sheet, with arms tucked at sides, hands on abdomen, and all secured with wide tape around torso, to bed, "swaddled".Prepped, draped, and equipment connected.Incision at 1238.In first 3 minutes of surgery, patient observed to be shaking intermittently.The esu module showed appropriate "green" good contact icon for grounding pad.This was the second case of the day, and all equipment was used without issue on the previous case.She was wearing biss monitor (forehead monitoring strip) and level of anesthesia appeared appropriately deep.Bair hugger was on high for temp control.It was noted then that patient's body appeared to shake specifically when bovie cautery used and stopped when bovie use was stopped.The surgeons immediately stopped the procedure while circulator rn disconnected grounding pad from her right thigh and applied a new bovie grounding pad to patient's other anterior/ lateral thigh (left) and connected it to the esu module.The bovie pencil was disconnected from the esu module and was removed from the sterile field and a new one given to the st.At 1245, the procedure resumed and no further shaking of the patient's body was observed at all, and especially observed during bovie cautery use.The procedure continued without issues.At the end of the procedure, when the patient's body was unwrapped from the positioning "swaddle", both grounding pad sites, right and left thighs, were examined closely by rn circulator and st in room, and were both clean, dry, and intact.This was communicated to surgical resident dr.[redacted name], who was in the room.The right thigh grounding pad had been in use when body shaking occurred.That site was clean, dry, intact, and with minimal small area pinkness that resolved within 10 seconds of grounding pad being removed.Patient's skin is ethnically white, so able to easily assess coloration.Patient left or at 1510, drowsy, calm, and stable.Equipment/ devices connected to patient: esu valley lab ft10 sn: [redacted number].Covidien smoke evacuator- (b)(6).Harmonic - (b)(6).Nerveana- (b)(6).Bair hugger- (b)(6).Neptune suction (unknown sn).Grounding pad at start of procedure at 1230, to right anterior/ lateral thigh- 3m- lot# 202406gy.Exp: [redacted date].Bovie pencil part of nwh cardinal health sterile minor pack sba13mintl lot# 762211.Mfg date: [redacted date] exp: [redacted date] new grounding pad applied to left thigh- covidien ref# e7507, lot# 213540236t exp: [redacted date].New bovie pencil- conmed ref# 130309a, lot# 202111084 exp: [redacted date].

• Brand Name: CARDINAL HEALTH NWH MINOR PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16794613
• MDR Text Key: 313812920
• Report Number: 16794613
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023,08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 762211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Sex: Female