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

Model Number	MAX-A
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/12/2023
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 xeroform gauze was used to treat a wound that resulted during patient discharge when the complaint device's sticky adhesive pulled/tugged on the patient skin, ripping a piece of their skin off with the complaint device right under the nail.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 july 11th, 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 returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, evidence of clinical use was identified.No evidence of tissue or irregularities was identified.The sensor/led was aligned with the primary tape per the acceptance criteria.Inspection of the device did not reveal any exposed wires.The connector and pins appeared to be intact.Inspection of the primary tape found adhesive to be present and was sticky to the touch.The results of the visual inspection determined that the reported event was not confirmed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause is user expectation.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.
Event or Problem Description
It was reported that xeroform gauze was used to treat a wound that resulted during patient discharge when the complaint device's sticky adhesive pulled/tugged on the patient skin, ripping a piece of their skin off with the complaint device right under the nail.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: 17295227
• Report Number: 3020163307-2023-00216
• Device Sequence Number: 11771458
• Product Code: NLF
• UDI-Device Identifier: 00885825014612
• UDI-Public: 00885825014612
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/09/2023

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-A
• Device Catalogue Number: MAX-ARR
• Device Lot Number: 026985426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 50 YR
• Patient Sex: Female