MAUDE Adverse Event Report: PARKER MEDICAL PARKER; ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 37 FR

Model Number	I-PSTDL-37
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 16 may 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 complaint (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, during laparoscopic resection of a malignant lung tumor, a tracheal tube was inserted into the patient in the supine position.After the patient's position was changed to the left side lying position the patient was checked with a bronchial fiberglass and a leak from the bronchial cuff was discovered.The patient was returned to the supine position and reintubated.The cuff was [subsequently] inspected and a cut was verified; there was no reported injury to the patient.
Additional Manufacturer Narrative
Correction: d4; e1.Additional informatio- investigation conclusion: h6; h11.The actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence of the reported malfunction; evaluation of this evidence confirmed the complaint as reported.The root cause could not be determined.Dhr: the vendor was notified of the incident.All information reasonably known as of 15 aug 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, during laparoscopic resection of a malignant lung tumor, a tracheal tube was inserted into the patient in the supine position.After the patient's position was changed to the left side lying position the patient was checked with a bronchial fiberglass and a leak from the bronchial cuff was discovered.The patient was returned to the supine position and reintubated.The cuff was [subsequently] inspected and a cut was verified; there was no reported injury to the patient.

• Brand Name: PARKER
• Common Device Name: ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 37 FR
• Manufacturer (Section D): PARKER MEDICAL; 9457 s. university blvd; pmb 331; highlands ranch CO 80126
• Manufacturer (Section G): WELL LEAD MEDICAL CO; c-4 jinhu industrial estate; hualong; panyu, guangzhou, jp 51143 4; JA 511434
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22038654
• Report Number: 3000219639-2025-00048
• Device Sequence Number: 8123423
• Product Code: CBI
• UDI-Device Identifier: 00607411959493
• UDI-Public: (01)00607411959493(10)2410DL2952D
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: I-PSTDL-37
• Device Catalogue Number: I-PSTDL-37
• Device Lot Number: 2410DL2952D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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
• Patient Sex: Unknown