MAUDE Adverse Event Report: CAREFUSION - ST. LOUIS TEBBETTS FIBEROPTIC SS RETR 15CMX30MM; GASTROENTEROLOGY/UROLOGY

Model Number 88-1088

Device Problem Overheating of Device (1437)

Patient Problem Blister (4537)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

Pr#: (b)(4).21dec2022 writer sent the customer an email acknowledging receipt of the complaint 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 Description

Mat#: 88-1088, lot#: unknown.Patient possibly burned by suction port on retractor during case resulting in two circular blisters on patient skin.03jan2022 additional information: 1.What was the procedure that was being performed? breast reconstruction with tissue expanders.2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? no.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.4.What was the patient¿s outcome? blisters were noted in 2 areas on the patient¿s chest.5.Was the procedure completed as planned? yes 6.Can you please send all parts of the instrument for evaluation and provide a shipper address? yes.7.What is the lot number? na.8.Do you have photos of the reported issue on the instrument? no.

Manufacturer Narrative

(b)(6) follow up mdr upon receipt the complaint sample received a visual examination and a functional check.The following markings were found on the device: snowden pencer, 88-1088, an (b)(6).Evidence was found that the device may not be authentic.Because of the absence of a date code on this device, all revisions of 55-1088 and 88-1088 were referenced for this determination.There is no evidence of gold plating having ever occurred on this device, in spite of the oldest revision of 88-1088 identified indicating this product has always received gold plating.It does have a date code etched on the suction fixture tubing in spite of all revisions of 88-1088 indicating is should.Based on its physical attributes, it originates from 58-1088 revision e which was active from july 2003 to july 2014.Based on that the fiber optic fixture tubing should also be etched with a ¿ce¿ mark, and the fiber optic fixture should be marked 3.5mm.As this is a purchased good, there is at least some opportunity for this part to not be authentic, but have been etched with the bare minimum to appear as a genuine snowden pencer product.The complaint description indicates the patient experienced two circular blisters on skin.Based on the use of the word skin, as opposed to tissue, and the fact that the distal end of the fiber optics and suction tubing are staggered, it is the belief that the customer is indicating the proximal end of the device caused the blisters, and that the circular blisters may not be a direct implication that the surface that caused the blisters is also circular.Additionally, it was observed that the wrong fiber optic cable was used, specifically a larger fiber optic cable than what should be used, a mismatch which will cause a heat issue at the adapter at the distal end of the device.The complaint sample 88-1088 was also returned with a fiber optic cord 88-9761with w/o # (b)(4) etched on it.This product is a 5.0 mm cable, which is the incorrect size cable for this retractor per the retractor¿s instructions for use (ifu), 36-6269, which amount other things, clearly states do not use fiber optic cables later than 3.5mm.The reason for this is that light energy transitions into heat energy when it can¿t be transmitted as light energy.When light travelling through the larger 5.0mm fiber optic cable strikes the 3.5mm adapter at the proximal end of the device, the optical fibers at the outer edge of the cord have no optical fibers on the retractor to transmit to and the light on the outer edges of the cable strikes solid metal heating up the fitting.Two other critical statements in the ifu for this device are 1) ¿this devices transmits high energy light.The metal connectors of the fiber optic bundle and the exposed tip may become hot during use.Never lay the device on a patient or on patient drapes¿ and 2) ¿when the device is connected to a light source, but not actively in use, keep the light source output off or at a minimum setting.Failure to do so may cause excessive heating of the metal connectors of the fiber optic bundle and the exposed tip and increase the potential for thermal burn.¿ investigator is not an expert in breast reconstruction with tissue expanders, however, after reviewing a video of a procedure, investigator infers that these instructions were not followed, in addition to the wrong optical cable size, for the skin to have been burnt, it would seem the retractor must have rested on the patient, and that the heat issue may have been worsened by leaving the light source on.The physical device was inspected.As stated earlier, light energy that cannot be further transmitted from one device to another transitions into heat energy, this can also result due to a damaged or soiled components along the lights path.Both ends of the fiber optics on retractor 88-1088 were observed to be transmit light well.The fiber optic cable was inspected as well and did not show any major signs of light transmission issues either.Because a date code was not detectable on the complaint sample, both a complaint history check and a device history record (dhr) review could not be performed.Based on: 1) the fact that a larger (5.0mm) fiber optic cable was used, in spite of instructions to use a cable larger than 3.5 mm in the ifu, 2) the absence of any significant soil or damage in the retractor or the fiber optic cable to create an abnormal heat hazard 3) the inability to perform a complaint history check or a device history review due to several expected laser etched markings missing from the device including a date code and 4) the customer¿s statements that the retractor caused blisters on the patient¿s skin/ chest, the most probable root cause of the complaint failure mode is a failure to follow the instructions of the ifu by the customer, namely don¿t use a cable larger than 3.5mm and never lay the device on a patient or on patient drapes.H3 other text : see h10.

Event Description

Mat# 88-1088 lot# unknown.Verbatim: patient possibly burned by suction port on retractor during case resulting in two circular blisters on patient skin.03jan2022 additional information: 1.What was the procedure that was being performed? [] breast reconstruction with tissue expanders.2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved?[] no.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray?[] no.4.What was the patient¿s outcome?[] blisters were noted in 2 areas on the patient¿s chest.5.Was the procedure completed as planned?[] yes.6.Can you please send all parts of the instrument for evaluation and provide a shipper address?[] yes.7.What is the lot number?[] na.8.Do you have photos of the reported issue on the instrument?[] no.

• Brand Name: TEBBETTS FIBEROPTIC SS RETR 15CMX30MM
• Type of Device: GASTROENTEROLOGY/UROLOGY
• Manufacturer (Section D): CAREFUSION - ST. LOUIS; 5 sunnen dr; saint louis MO 63143
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer Contact: andrew elia ; 5 sunnen drive; st. louis, MO 63143 ; 8015652341
• MDR Report Key: 16163529
• MDR Text Key: 307469516
• Report Number: 1923569-2023-00002
• Device Sequence Number: 1
• Product Code: FDG
• UDI-Device Identifier: 10885403151675
• UDI-Public: (01)10885403151675
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2023,02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88-1088
• Device Catalogue Number: 88-1088
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2023
• Event Location: Hospital
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other