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

Model Number SBT-321-100

Device Problems Material Separation (1562); Material Integrity Problem (2978)

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

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a bite blox was used during an upper endoscopy, including gastrostomy procedure performed on (b)(6) 2021.During the procedure, it was noted that the bite blox was broken into several pieces by patient's front teeth and the hose of the gastric camera as well as the scope channel were flattened.The broken pieces were successfully removed from the patient's mouth.The procedure was completed with another scope and another of the same 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 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: 11467002
• MDR Text Key: 239422257
• Report Number: 3005099803-2021-01031
• Device Sequence Number: 1
• Product Code: MNK
• UDI-Device Identifier: 00816849016764
• UDI-Public: 00816849016764
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SBT-321-100
• Device Catalogue Number: SBT-321-100
• Device Lot Number: 0000201011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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
• Patient Age: 69 YR
• Patient Weight: 60