MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; BALLOON

Model Number	OE-A52
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 30-aug-2024, pentax medical became aware of of an initial report of shipment of three (3) expired balloon kits received at the user facility: #1- containing one (1) box was that was shipped to the user facility on 24-jun-2024, with an expiration date of 30-jun-2024.#2- containing two (2) boxes that were shipped to the user facility on 14-aug-2024 with the same expiration date (30-jun-2024).There was no report of patient harm.Description of any actions taken: identified the orders per below: box number 1 was shipped on 31-jun-2024.Box number 2 was shipped on 13-aug-2024.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
Additional Manufacturer Narrative
H6:continued: health effect - clinical code : 4582 no clinical signs, symptoms or conditions health effect - impact code : 4652 exposure to contaminated device/risk of infection medical device problem code : 1421 delivered as unsterile product component code : 419 balloon type of investigation : 4118 type of investigation not yet determined investigation findings : 4246 transport/storage problem identified, 3233 results pending completion of investigation investigation conclusions : 11 conclusion not yet available g4: this device is not distributed in the usa, therefore the pma/510(k) number is not applicable.Additional information no known intervention done to the patient as a result of the event.Patient info unknown.The sterilization expiration date for this balloon was 30-jun-2024, 1.5 months exceeded.Pentax medical states that the sterilization period for target balloons is two years.Based on the investigation, tests for product function, deterioration of the packaging material, and biological risks were conducted and confirmed that the criteria were met during the following period for each test.-product function: four years and six months -package integrity: three years and three days -biological risks: three years and one month based on the above results, endoscopic examinations were performed using balloons that had exceeded sterilization expiration up to 1.5 months.However as it was within the acceptable period in tests for product function, deterioration of the packaging material, and biological risks.Therefore, it was determined that these complaints did not lead a dangerous situation.Although a total of twenty-two(22) (twelve (12) from box #1, and ten(10) from box #2) sterilization-expired balloons were used for examination, no patient health damage was reported.Device history records were reviewed based on the lot numbers of the balloons, and no deviation or nonconformity was found.In addition, the remaining expiration period at the time of shipment from the miyagi factory it was confirmed that the remaining expiration period was more than 530 days.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Manufacturer mdr 9610877-2024-00093_oe-a52_1011082_expired balloons_patient 01(box1) manufacturer mdr 9610877-2024-00094_oe-a52_1011082_expired balloons_patient 02(box1) manufacturer mdr 9610877-2024-00095_oe-a52_1011082_expired balloons_patient 03(box1) manufacturer mdr 9610877-2024-00096_oe-a52_1011082_expired balloons_patient 04(box1) manufacturer mdr 9610877-2024-00097_oe-a52_1011082_expired balloons_patient 05(box1) manufacturer mdr 9610877-2024-00098_oe-a52_1011082_expired balloons_patient 06(box1) manufacturer mdr 9610877-2024-00099_oe-a52_1011082_expired balloons_patient 07(box1) manufacturer mdr 9610877-2024-00100_oe-a52_1011082_expired balloons_patient 08(box1) manufacturer mdr 9610877-2024-00101_oe-a52_1011082_expired balloons_patient 09(box1) manufacturer mdr 9610877-2024-00102_oe-a52_1011082_expired balloons_patient 10(box1) manufacturer mdr 9610877-2024-00103_oe-a52_1011082_expired balloons_patient 11(box1) manufacturer mdr 9610877-2024-00104_oe-a52_1011082_expired balloons_patient 12(box1) manufacturer mdr 9610877-2024-00105_oe-a52_1011082_expired balloons_patient 01(box2) manufacturer mdr 9610877-2024-00106_oe-a52_1011082_expired balloons_patient 02(box2) manufacturer mdr 9610877-2024-00107_oe-a52_1011082_expired balloons_patient 03(box2) manufacturer mdr 9610877-2024-00108_oe-a52_1011082_expired balloons_patient 04(box2) manufacturer mdr 9610877-2024-00109_oe-a52_1011082_expired balloons_patient 05(box2) manufacturer mdr 9610877-2024-00110_oe-a52_1011082_expired balloons_patient 06(box2) manufacturer mdr 9610877-2024-00111_oe-a52_1011082_expired balloons_patient 07(box2) manufacturer mdr 9610877-2024-00112_oe-a52_1011082_expired balloons_patient 08(box2) manufacturer mdr 9610877-2024-00113_oe-a52_1011082_expired balloons_patient 09(box2) manufacturer mdr 9610877-2024-00114_oe-a52_1011082_expired balloons_patient 10(box2).
Event or Problem Description
This follow up report for mdr 9610877-2024-00108 serves as a retraction of the initial report invalidating the september 18, 2024 initial submission.Refer to h11 for additional details.
Additional Manufacturer Narrative
Correction information: b4: date of this report.B5: refer to h11.G6: follow up #1.H2: if follow-up, what type? h3: device evaluated by manufacture.Additional information: d4: primary unique device identifier (udi) #.H4: device manufacture date.Evaluation summary: a capa investigation has been initiated car 2024-003.Summary of capa as follows: hospital confirmed that all remaining expired balloons have been disposed of.Pentax has provided replacement product.All oe-a52 inventory was reviewed for expired/close to expired.No additional expired product was found.All products in pci warehouse with expiry dates were reviewed for expired/close to expired.No additional expired product was found.As scopes are packaged with a box of balloons (20x) and other accessories, all scope cases (all warehouses - stock, loaner, demo) were checked to confirm no expired balloons were contained.One pkg of 20 in demo was close to expiry and this was removed.No expired product was found.Storage, handling and delivery sop is being updated to more explicitly describe processes for managing expiry dating.Hra (health hazard evaluation and health risk assessment) was performed.Regarding the reported complaints, endoscopy was performed using a balloon that had exceeded its sterilization expiration date by up to 1.5 months.Based on the results of the tests of product function, deterioration of packaging materials, and biological risk, it was confirmed that there were no problems with product efficacy and safety during the concerned period.In addition, a total of 27 balloons with expired sterilization dates were used for endoscopy, but there were no reports of patient health hazards.Based on the above investigation results, pentax medical re-evaluated whether mdr was necessary and determined that mdr was not necessary.The dhr review confirmed the endoscope was manufactured pentax medical manufactured on 14-jul-2022 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment on 04-aug-2022 and actual date shipped were confirmed on 09-aug-2022.This follow up report for mdr 9610877-2024-00108 serves as a retraction of the initial report invalidating the september 18, 2024 initial submission.Refer to h11 for additional details.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Manufacturer mdr 9610877-2024-00093_oe-a52_1011082_expired balloons_patient 01(box1).Manufacturer mdr 9610877-2024-00094_oe-a52_1011082_expired balloons_patient 02(box1).Manufacturer mdr 9610877-2024-00095_oe-a52_1011082_expired balloons_patient 03(box1).Manufacturer mdr 9610877-2024-00096_oe-a52_1011082_expired balloons_patient 04(box1).Manufacturer mdr 9610877-2024-00097_oe-a52_1011082_expired balloons_patient 05(box1).Manufacturer mdr 9610877-2024-00098_oe-a52_1011082_expired balloons_patient 06(box1).Manufacturer mdr 9610877-2024-00099_oe-a52_1011082_expired balloons_patient 07(box1).Manufacturer mdr 9610877-2024-00100_oe-a52_1011082_expired balloons_patient 08(box1).Manufacturer mdr 9610877-2024-00101_oe-a52_1011082_expired balloons_patient 09(box1).Manufacturer mdr 9610877-2024-00102_oe-a52_1011082_expired balloons_patient 10(box1).Manufacturer mdr 9610877-2024-00103_oe-a52_1011082_expired balloons_patient 11(box1) manufacturer mdr 9610877-2024-00104_oe-a52_1011082_expired balloons_patient 12(box1).Manufacturer mdr 9610877-2024-00105_oe-a52_1011082_expired balloons_patient 01(box2).Manufacturer mdr 9610877-2024-00106_oe-a52_1011082_expired balloons_patient 02(box2).Manufacturer mdr 9610877-2024-00107_oe-a52_1011082_expired balloons_patient 03(box2).Manufacturer mdr 9610877-2024-00109_oe-a52_1011082_expired balloons_patient 05(box2).Manufacturer mdr 9610877-2024-00110_oe-a52_1011082_expired balloons_patient 06(box2).Manufacturer mdr 9610877-2024-00111_oe-a52_1011082_expired balloons_patient 07(box2).Manufacturer mdr 9610877-2024-00112_oe-a52_1011082_expired balloons_patient 08(box2).Manufacturer mdr 9610877-2024-00113_oe-a52_1011082_expired balloons_patient 09(box2).Manufacturer mdr 9610877-2024-00114_oe-a52_1011082_expired balloons_patient 10(box2).

• Brand Name: PENTAX
• Common Device Name: BALLOON
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 20252853
• Report Number: 9610877-2024-00108
• Device Sequence Number: 8667226
• Product Code: EOQ
• UDI-Device Identifier: 04961333146062
• UDI-Public: (01)04961333146062(11)220714(17)240630(10)1011082
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: OE-A52
• Device Lot Number: 1011082
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown