MAUDE Adverse Event Report: CONMED CORPORATION SCOPE SAVER BITE BLOCK - LATEX FREE

Catalog Number	000429
Medical Device Problem Code	Failure To Unwrap (2940)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned to the conmed quality assurance laboratory for evaluation.No visual evidence (photographs) of failure "difficult to unwrap" was made available.A failure analysis of the complaint device could not be completed therefore the reported failure cannot be verified; the complaint is unconfirmed.This lot was manufactured on 04-nov-2016.A review of the manufacturing documents from the dhr/lhr have been reviewed with special attention to the manufacturing and inspection of this product.The products released for distribution were found to have met all specifications prior to shipment.Of the lot containing (b)(4) units, there was no other similar complaint received for this item and lot number combination.This is an isolated event.A two (2) year review of product history for this device family showed no other complaints for similar failure mode.(b)(4).In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risk of possible compromised packaging.The ifu states: "inspect package for damage.If damaged, do not use." there have been no previous adverse events related to the product and failure mode per a two-year review, however due to the reported complaint further investigation has been initiated.
Event or Problem Description
The user facility reported that during an esophagogastroduodenoscopy (egd), the physician noticed a foreign body in the esophagus.The physician removed the small piece of plastic with a roth net device.The facility stated "the plastic piece fit exactly into where the packaging had been torn on bite block.The bite block package had ripped open but not on designated perforated line." there was no patient or user injury with this reported incident.This report is filed on the basis of potential injury with recurrence.Multiple attempts for further information has been requested from user facility, but none has been received to date.If additional information is received, it will be included in the supplemental and final report.

• Brand Name: SCOPE SAVER BITE BLOCK - LATEX FREE
• Common Device Name: BITE BLOCK
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6477052
• Report Number: 3007305485-2017-00087
• Device Sequence Number: 582615
• Product Code: KTI
• UDI-Device Identifier: 20653405050282
• UDI-Public: (01)20653405050282(17)181104(10)201611044
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K833491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 11/04/2018
• Device Catalogue Number: 000429
• Device Lot Number: 201611044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/10/2017
• 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: Required Intervention