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

Model Number SBT-114-100

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a bite blox was used during an endoscopic ultrasound performed on (b)(6) 2022.During the procedure, the mouthpiece was damaged by the force of the teeth.The fragments came out when the scope was pulled out and removed from the mouth.The procedure was completed with another bite blox.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: device code a0413 captures the reportable event of bite blox material separation.Block h10: investigation results the returned bite blox was analyzed.Visual evaluation found that the bite blox was returned in three pieces.The lower bite tray was broken and separated into two pieces.No other problems were noted.The reported event was confirmed.Product analysis identified that the device had a broken bite tray.It was reported that the device broken from the patient's bite during use.It is likely that adverse procedural factors related to patient response may have contributed to the reported event.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a bite blox was used during an endoscopic ultrasound performed on (b)(6), 2022.During the procedure, the mouthpiece was damaged by the force of the teeth.The fragments came out when the scope was pulled out and removed from the mouth.The procedure was completed with another bite blox.There were no patient complications reported as a result of this event.

• Brand Name: BLOX
• Type of Device: 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 LTD; 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: 15099060
• MDR Text Key: 304707410
• Report Number: 3005099803-2022-03792
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1