MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

Model Number EG27-I10

Device Problems Difficult to Remove (1528); Scratched Material (3020)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of an event that occurred in the operating room during use in (b)(6).The user initially reported that the patient was undergoing removal of gi band procedure under general anaesthetic.Several different instruments were being used in addition to the pentax medical video gastroscope, model eg27-i10, serial number (b)(4).The eg27-i10 endoscope working channel was damaged during the procedure and the endoscope was returned for repair to (b)(4) and received on august 7, 2020.The repair order noted that "grasping forceps were stuck in the scope and forcefully removed by dr." there was no mention of patient injury with the repair request at this time.Pentax (b)(4) assessed the damage and confirmed the damage to the working channel.Upon pentax (b)(4) notification to the hospital of the repair assessment on august 11, 2020, the hospital responded to please return the scope as there had been an adverse event but provided no further details.(b)(4) returned the scope to the hospital unrepaired.On august 25, 2020, the complainant provided a medical device incident harm or potential for serious harm/death vendor communication and investigation agreement to (b)(4).No information about the adverse event or patient injury was provided at that time.In a follow up call on august 27, 2020, the complainant reported to (b)(4) that at some point during the procedure, the patient's tongue was severed (glossectomy).The complainant is not sure when or how this occurred.The complainant stated that the damage to the working channel occurred possible due to the grasper jaws being removed in an open position but he was not sure.He also stated the patient injury was likely not from the endoscope but occurred due to one of the other instruments.The complainant also reported that after the incident, the patient was referred to plastic surgery but it was determined the tongue could not be reattached.No other patient information was available.On august 28, 2020, the hospital shared the (b)(6) report with pentax (b)(4).In it the consequences to the patient are described as: "avulsion of the tongue" and incident details are described as: "endoscopic scope and wire inserted for the intended procedure.Wire fed through olympus sheath and into the handle.Sheath connected to handle and screwed into place.Wire tightened in order to advance to upper gi.During the retrieval of the wire and scope from the stomach, anesthetist noticed patient "hemorrhaging" from mouth." the investigation is in-process.

Manufacturer Narrative

Evaluation summary: this is an event in which a foreign matter such as a brush clogs the pipe.The cause is thought to be that the brush used by the user during cleaning was broken and remained in the pipe.Correction information: g6: follow up #1.H2: type of follow up.Additional information: h4: device manufacture date.H6: coding changed based on the investigation result.H7: remedial action.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 10623320
• MDR Text Key: 216309730
• Report Number: 9610877-2020-00176
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333223022
• UDI-Public: 04961333223022
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG27-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other