MAUDE Adverse Event Report: JIANGSU JIANYU HEALTH MEDICAL CO LTD BLOX; ENDOSCOPIC BITE BLOCK

Model Number	SBT-114-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number.Therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0413, captures the reportable event of bite blox material separation.
Event or Problem Description
It was reported, to boston scientific corporation.That a bite blox was used, during a gastroscopy procedure on (b)(6) 2024.During the procedure, the bite blox got chipped.Nothing detached inside the patient.It was reported, the device was not inspected, prior to the procedure.The procedure was completed with another bite blox.There were no reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during a gastroscopy procedure on (b)(6) 2024.During the procedure, the bite blox got chipped.Nothing detached inside the patient.It was reported the device was not inspected prior to the procedure.The procedure was completed with another bite blox.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.Block h10: investigation results: the returned bite blox was analyzed.Visual inspection of the returned device showed signs of damage in the form of a break on one side of the mouthpiece.Bite marks were also present.No material defects/deformation were noted with the returned device or the surrounding area of the break.The reported event was confirmed.Product analysis identified that one side of the mouthpiece was damaged/broken.Evidence that the device was used was also noted in the form of witness marks/bite marks.Nonconformances that could have caused the reported failure were not found per the dhr review and/or the investigation report.No material defects or deformations were noted at the site of the break/damage.Based on all gathered information, the complaint investigation conclusion code selected is cause traced to component failure indicating that the noted damage to the device is due to an expected or random component failure without any design or manufacturing issue.

• Brand Name: BLOX
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): JIANGSU JIANYU HEALTH MEDICAL CO LTD; zhixi industry zone; jintan area; changzhou city 21325 1; CH 213251
• Manufacturer (Section G): JIANGSU JIANYU HEALTH MEDICAL CO LT; no 88 of longxi avenue; zhulin town; changzhou city 21324 1; CH 213241
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19885887
• Report Number: 3005099803-2024-03602
• Device Sequence Number: 7115287
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: SBT-114-100
• Device Catalogue Number: SBT-114-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 10/16/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown