MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BIOSHIELD IRRIGATOR; BIOPSY VALVE

Model Number	00711133
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up with the user facility, steris endoscopy has learned that the bioshield irrigator was used in conjunction with an extension tubing set not manufactured by steris endoscopy, contrary to the bioshield instructions for use.One device subject of this complaint was returned to steris endoscopy for evaluation.Testing of the returned device could not reproduce the reported event.Statements from the instructions for use prior to insertion of the device into the endoscope include: " to irrigate.Open the pinch clamp on the irrigation line; attach part 00711134 bioshield irrigator extension tubing to compatible auxiliary water pump, securing the male end of the tubing to the bioshield device's irrigation line." the device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Steris endoscopy has offered in-service training on the use of the bioshield irrigator; however, the user facility has declined.
Event or Problem Description
The user facility reported two instances of patient material in the tubing connected to the one-way valve of the bioshield irrigator following a patient procedure.The tubing and water bottle were replaced prior to the next procedure.There was no report of patient harm nor of procedural delay.

• Brand Name: BIOSHIELD IRRIGATOR
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 10521139
• Report Number: 1528319-2020-00032
• Device Sequence Number: 19538784
• Product Code: ODD
• UDI-Device Identifier: 00816765011102
• UDI-Public: (01)00816765011102
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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 Expiration Date: 10/02/2022
• Device Model Number: 00711133
• Device Catalogue Number: 00711133
• Device Lot Number: 1913865
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1