MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH PK INSTRUMENT "PK MORCELLATOR", STERILE, SINGLE USE

Model Number WA90200A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The referenced device was not returned to the manufacturer.However, based on the information reported, the most probable cause of the reported event can be attributed to (unintended operator error) as the user facility reported a zero degree scope was used for vision inside of the referenced pneumoliner containment bag contrary to the instruction manual (ifu).The ifu for the pneumoliner bag provides caution that indicates, "device should only be used with 5mm laparoscopes with =30° lens angle or deflectable tip." additionally, to mitigate the risk of patient injury the pk morcellator's ifu provides warning that states: make sure to maintain the minimum insertion depth, i.E.The symbol section at the tip is visible within the abdominal cavity.This ensures that the tip does not touch the abdominal wall before and during activation.A review of the dhr performed by the oem for the concerned device indicated there were no issues (ncrs or deviations) within the manufacturing process which might explain the failures observed.

Event Description

On august 19, 2019, the manufacturer received a medwatch report (# mw5088411) that states: the patient was admitted for a laparoscopic hysterectomy as uterine fibroids were identified prior to the surgery.The patient's uterus was dissected off the uterine wall and the pk morcellator device was used with a zero degree lens for visualization.During, the course of removal of the uterus from the pneumoliner containment bag, pieces of the patient's bowel were identified and the bowel was damaged.The use of the pk morcellator was stopped and the patient underwent a change in procedure as a bowel resection was performed.Three units of blood were provided to the patient.The pneumoliner bag was found to have damage and the morcellator came in contact with patient's small bowel.The patient was discharged home.Per follow-up information, the patient is home and has returned to normal bowel function, approximately 20 cm of small bowel was resected under general surgery.

• Brand Name: PK INSTRUMENT "PK MORCELLATOR", STERILE, SINGLE USE
• Type of Device: PK MORCELLATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 9071394
• MDR Text Key: 158698365
• Report Number: 9610773-2019-00122
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 14042761082928
• UDI-Public: 14042761082928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/16/2019

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
• Device Operator: Health Professional
• Device Model Number: WA90200A
• Device Lot Number: U1707046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CONTAINMENT BAG: OLYMPUS WA90500US, LOT 113202; TELESCOPE: 0 DEGREE LENS (MAKE/MODEL/SERIAL UNK)
• Patient Outcome(s): Required Intervention