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

Model Number WA90200A

Device Problem Break (1069)

Patient Problem Bowel Perforation (2668)

Event Date 06/12/2019

Event Type  Injury  

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
• MDR Report Key: 9071383
• MDR Text Key: 160322359
• Report Number: 2951238-2019-01118
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 14042761082928
• UDI-Public: 14042761082928
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• 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

• Date FDA Received: 09/16/2019
• 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?: Yes
• Date Report Sent to FDA: 09/16/2019
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention