MAUDE Adverse Event Report: SALTER LABS PARKER; PARKER ENDO-BRONCH WITH STANDARD TIP (LEFT DOUBLE-LUMEN ENDOBRONCHIAL TUBE)

Model Number	I-PSTDL-37 (SALTER H-PSTDL-37)
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 19 dec 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported that after the operation, medical staff observed a laceration in the membranous portion of the left main bronchus, located at the position of the blue cuff.A thoracotomy was performed, and the damaged area was sutured.No additional information was provided regarding the patient's outcome.
Additional Manufacturer Narrative
The product associated with the complaint was not returned for evaluation, and no photographic or videographic evidence was provided.In the absence of visual documentation, the complaint could not be confirmed; furthermore, without a sample for functional testing, the root cause could not be determined.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 04 mar 2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by represents all of the information known at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement, and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
It was reported that after the operation, medical staff observed a laceration in the membranous portion of the left main bronchus, located at the position of the blue cuff.A thoracotomy was performed, and the damaged area was sutured.No additional information was provided regarding the patient's outcome.

• Brand Name: PARKER
• Common Device Name: PARKER ENDO-BRONCH WITH STANDARD TIP (LEFT DOUBLE-LUMEN ENDOBRONCHIAL TUBE)
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167 parq; ind. las ameri - hor sur cd ju; chihuahua 32596 ; MX 32596
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 23857698
• Report Number: 3004748541-2025-00152
• Device Sequence Number: 16045922
• Product Code: CBI
• UDI-Device Identifier: 00607411959493
• UDI-Public: (01)00607411959493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: I-PSTDL-37 (SALTER H-PSTDL-37)
• Device Catalogue Number: I-PSTDL-37 (SALTER H-PSTDL-37)
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/04/2026
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 52 KG