MAUDE Adverse Event Report: CAREFUSION, INC REUSABLE PROBE SUCT COAGULATOR 5MM 32CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	88-9100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).On 16aug2021 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
Event or Problem Description
Per complaint details received: multiple reusable suction electrodes are not providing cauterization and have occasional leaking.One instrument burned the surgeon's hand on (b)(6) 2021.On 24aug2021 additional information: no medical attention was needed for the surgeon.This issue of no coagulation has been going on and we are looking for a solution.No further information available.
Event or Problem Description
Per complaint details received: multiple reusable suction electrodes are not providing cauterization and have occasional leaking.One instrument burned the surgeon's hand on (b)(6) 2021.24aug2021 additional information: no medical attention was needed for the surgeon.This issue of no coagulation has been going on and we are looking for a solution.No further information available.
Additional Manufacturer Narrative
(b)(4).Follow up: the complaint product was returned, and an evaluation was performed.The root cause of the issue is undetermined.Instrument 88-9100 batch no.G30237 indicates that the product is not a trokamed product.(the trokamed supplier code for bd is ¿xtr¿: every batch number of a trokamed product starts with this prefix).Additionally, there are some differences on a design level in comparison to our standard product mos05001.The serial number is unknown.Trokamed manufactures for bd with lot code xtr.Also, the instrument marking is black, not white as usually done by trokamed.As can be seen on the customer¿s complaint instrument, the black insulation does not extend to just before the working end, as is usual with the trokamed instrument.Perhaps the instrument was rebuilt.The product would have been manufactured and tested according to the specifications.A review of the device history records (dhr) could not be performed as the lot code is not accurate.There have been no issues identified with the material or manufacturing process.

• Brand Name: REUSABLE PROBE SUCT COAGULATOR 5MM 32CM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 12413963
• Report Number: 1423507-2021-00043
• Device Sequence Number: 3308465
• Product Code: GEI
• UDI-Device Identifier: 10885403154546
• UDI-Public: (01)10885403154546
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: 88-9100
• Device Catalogue Number: 88-9100
• Device Lot Number: G40237
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other