MAUDE Adverse Event Report: STRYKER-ENDOSCOPY TIJUANA MX; OXIMETER, REPROCESSED

Model Number	MAX-N
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Inflammation (1932)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.
Event or Problem Description
It was reported that after an operative surgery, the patient received anti-inflammatory treatment for a burn at the complaint device's attachment site on their foot.There was no other patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The received medical opinion obtained on (b)(6), 2023, holds that the reported event falls into a description of s2 injuries at most.Additionally, the medical opinion holds that the reported treatment was not required to prevent a permanent impairment or loss of function, but rather to help expedite the recovery process or administered as standard preventative care.Therefore, this event is no longer considered mdr-reportable.The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned to stryker sustainability solutions, evaluation was unable to be performed.No device information was reported and the customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.The reported event could be attributed to: simultaneous use with incompatible equipment (as the monitor is responsible for delivering energy to the device, a faulty or incompatible monitor may deliver excessive energy to the led which may cause higher than normal temperatures at the led site) the patient has an allergic reaction to the adhesive causing a skin rash.The instructions for use (ifu) state: inspect the sensor site periodically to ensure correct sensor alignment and adhesion.Do not attempt to repair, modify, or clean sensor.When uncertain about any measurement accuracy, check the patient¿s vital signs by alternate means; then make sure then make sure the pulse oximeter is working properly.In conjunction to clinical signs and symptoms, pulse oximeter sensors are exclusively designed to be used as an adjunct in patient assessment.Sensor application errors, certain patient and ambient environmental conditions, can affect pulse oximeter¿s readings and signal.Any of the following conditions can cause inaccurate oxygen measurements failure to properly apply the sensor to the patient or to align the optical transducers application of sensor to an extremity with an arterial catheter, blood pressure cuff or intravascular infusion line in place.Application of sensor to a site that is too thick, thin or deeply pigmented.Venous pulsations if the sensor or supplemental tape is wrapped too tightly.Transducer exposure to excessive light.Cover the sensor with opaque material if it is suspected that the transducer is exposed to excessive ambient light.Intravascular dyes.Excessive motion.Locate sensor at a stationary site and try to keep patient still.Plug the sensor into the pulse oximeter module and verify proper operations as described in the system operator¿s manual.If the sensor does not indicate reliable tracking of the pulse rate, relocate sensor to an alternative site or choose an alternative sensor.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.H3 other text : 81.
Event or Problem Description
It was reported that after an operative surgery, the patient received anti-inflammatory treatment for a burn at the complaint device's attachment site on their foot.There was no other patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: OXIMETER, REPROCESSED
• Manufacturer (Section D): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana
• Manufacturer (Section G): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 17243237
• Report Number: 3020163307-2023-00215
• Device Sequence Number: 15130579
• Product Code: NLF
• UDI-Device Identifier: 00885825014322
• UDI-Public: 00885825014322
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: MAX-N
• Device Catalogue Number: MAX-NRR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Unknown