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
Updates to: g3, g6, h2, h6, and h10.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 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.
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 device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, evidence of clinical use was identified.Evidence of tissue on the sticky side was identified.The sensor/led was aligned with the primary tape per the acceptance criteria.Inspection of the device revealed exposed wires near the tap.The connector and pins appeared to be intact.Inspection of the primary tape found adhesive to be present and was sticky to the touch but not abnormally sticky.The results of the visual inspection determined that the reported event was 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 applicator error; applied to potentially previously compromised site (skin damage present); applied too tightly.The instructions for use (ifu) state: nspect the sensor site periodically to ensure correct sensor alignment and adhesion.Do not attempt to repair, modify or clean sensor.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.Excessive motion.Locate sensor at a stationary site and try to keep patient still.The reported event will continue to be monitored through post-market surveillance.

• 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: 17295262
• Report Number: 3020163307-2023-00217
• Device Sequence Number: 4070416
• 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,Followup
• Report Date (Section B): 05/10/2024

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 Expiration Date: 04/17/2026
• Device Model Number: MAX-A
• Device Catalogue Number: MAX-ARR
• Device Lot Number: 0000250852
• 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; 07/11/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/09/2023; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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: 45 YR
• Patient Sex: Male